US20040133273A1 - Apparatuses and methods for heart valve repair - Google Patents

Abstract

A medical device for treating a defective heart valve. The medical device comprises a delivery sheath and an implantable device moveably disposed within the delivery sheath. The implantable device further comprises a distal expandable basket, a proximal expandable basket, and a connecting member coupling at a first end to the distal expandable basket and at a second end to the proximal expandable basket. Each of the distal expandable basket and proximal expandable basket is in a collapsed state during delivery and an expanded state after deployment. An actuator is releasably coupled to the implantable device. When coupled to the implantable device, the actuator can move the implantable device in a way to allow for positioning of the distal and proximal expandable baskets.

Description

REFERENCE TO RELATED APPLICATION
• This is a continuation in part of application Ser. No. 10/295,714 filed on Nov. 15, 2002, attorney docket number 005618.P3635, which is hereby incorporated in its entirety by reference.[0001]
BACKGROUND OF THE INVENTION
• 1. Field of the Invention[0002]
• The present invention involves annuloplasty devices and delivery devices for the annuloplasty devices that are used for treating a medical condition such as a defective mitral valve.[0003]
• 2. Discussion of Related Art[0004]
• FIG. 1A illustrates a[0005]heart10. There are four valves in theheart10 that serve to direct the flow of blood through the two sides of theheart10 in a forward direction. The four valves are amitral valve20, anaortic valve18, atricuspid valve60, and apulmonary valve62 as illustrated in FIG. 1A. Themitral valve20 is located between theleft atrium12 and theleft ventricle14. Theaortic valve18 is located between theleft ventricle14 and theaorta16. These two valves direct oxygenated blood coming from the lungs, through the left side of the heart, into theaorta16 for distribution to the body. Thetricuspid valve60 is located between theright atrium22 and theright ventricle24. Thepulmonary valve62 is located between theright ventricle24 and thepulmonary artery26. These two valves direct de-oxygenated blood coming from the body, through the right side of the heart, into thepulmonary artery26 for distribution to the lungs, where it again becomes re-oxygenated and distributed to themitral valve20 and theaortic valve18.
• All of the heart valves are complex structures. Each valve consists of moveable “leaflets” that are designed to open and close. The mitral valve has two leaflets and the tricuspid valve has three. The aortic and pulmonary valves have leaflets that are more aptly termed “cusps” and are shaped somewhat like a half-moon. The aortic and pulmonary valves each have three cusps.[0006]
• Blood flows into the[0007]left ventricle14 through themitral valve20 that opens during diastole. Once the left ventricular cavity has filled, theleft ventricle14 contracts during systole. Themitral valve20 closes (the leaflets of themitral valve20 re-approximate) while theaortic valve18 opens during systole allowing the oxygenated blood to be ejected from theleft ventricle14 into theaorta16. A normal mitral valve allows blood to flow into the left ventricle and does not allow leaking or regurgitating back into the left atrium and then into the lungs during systole. The aortic valve allows blood to flow into the aorta and does not allow leaking (or regurgitating) back into the left ventricle. Thetricuspid valve60 functions similarly to the mitral valve to allow deoxygenated blood to flow into theright ventricle24. Thepulmonary valve62 functions in the same manner as theaortic valve18 in response to relaxation and contraction of theright ventricle24 in moving de-oxygenated blood into the pulmonary artery and thence to the lungs for re-oxygenation.
• With relaxation and expansion of the ventricles (diastole), the mitral and tricuspid valves open, while the aortic and pulmonary valves close. When the ventricles contract (systole), the mitral and tricuspid valves close and the aortic and pulmonary valves open. In this manner, blood is propelled through both sides of the heart.[0008]
• The anatomy of the heart and the structure and terminology of heart valves are described and illustrated in detail in numerous reference works on anatomy and cardiac surgery, including standard texts such as Surgery of the Chest (Sabiston and Spencer, eds., Saunders Pub]., Philadelphia) and Cardiac Surgery by Kirklin and Barrett-Boyes.[0009]
• In chronic heart failure (CHF), the size of the heart becomes enlarged. This enlargement can cause the annular size of the valves that separate the atria from the ventricles to also become enlarged. The mitral valve is generally the most affected and has the most serious effects on patient health. FIG. 1B illustrates a sectional view of the positions of the cardiac valves such as the[0010]mitral valve20 present in theheart10. The annular enlargements can become so pronounced that the leaflets of the valve(s) are unable to effectively close. The annular enlargement most profoundly affects theposterior leaflet25 of themitral valve20. FIG. 1C illustrates a sectional view of the expansion of theannulus28 of themitral valve20. As shown, theannulus28 expands from a cross-sectional size indicated by thenumber21 to the expanded cross-sectional size indicated by thenumber23. The expansion/enlargement typically affects theposterior leaflet25 of themitral valve20. During systole, due to the annular enlargement, the valve leaflets do not meet (valve not fully closed, no coaptation), thus some amount of blood flows the wrong way back through the valve from the ventricle and back into the atrium (valve regurgitation) where it raises the pressure in the atrium. This is termed “Mitral Valve Regurgitation” or MVR. MVR reduces the amount of blood pumped by the heart to the body. This reduction in blood flow can be life threatening, especially in patients that have lost ventricular tissue (i.e. heart attack victims), have contraction synchronization problems and/or other problems that reduce the heart's ability to act as a pump.
• Regurgitation is common, and is occurring in about[0011]7% of the population. Mitral valve regurgitation is caused by a number of conditions, including genetic defects, infections, coronary artery disease (CAD), myocardial infarction (N) or congestive heart failure (CHF). Most cases are mild and if the symptoms are bothersome, they can usually be controlled with drugs.
• In more serious cases, the faulty or defective valve can be repaired with a surgical procedure such as an annuloplasty. As illustrated in FIG. 1D, an[0012]annuloplasty30 is a surgical procedure in which asynthetic ring32 is placed around the valve rim (annulus)34.Sutures38 are put into thevalve annulus34 and thesynthetic ring32. This causes proper closing by shrinking the size of the valve opening36. Thesynthetic ring32 also reduces and reshapes theannulus34 to move the posterior leaflet toward the anterior leaflet. FIG. 1E illustrates another surgical procedure in which a heart valve such as themitral valve20 is repaired by reconstruction. First, at step A, a section P2 from theposterior leaflet40 of themitral valve20 is excised. Then, sequentially at steps B, C, D, and E, sections P1 and P3 of theposterior leaflet40 are sutured together. The reconstruction shrinks the size of the valve opening36. In some instances, a faulty or defective valve must be surgically replaced with a new valve. Examples of new valves include homograft valves (valves harvested from human cadavers), artificial mitral valves, and mechanical valves.
• All of the procedures above are typically major surgical procedures that require the opening of the chest by sternotomy or at best through-small incisions in the chest wall, performing a heart lung bypass and stopping the heart beat. While surgical procedures such as those mentioned can successfully reconstruct the valve back to a non-regurgitant state, this problem is often associated with Chronic Heart Failure (CBF) and/or other debilitating diseases and thus, the sufferers of the regurgitant valve are often unable to tolerate the required open heart surgery. In CHF patients, the heart is progressively less able to pump sufficient blood to meet the body's needs, usually due to the continuing enlargement of the left ventricle (and adjacent structures) in response to high blood pressure, high heart rate, ECG conduction/timing problems and/or insults to the ventricular tissue, such as Myocardial Infarct (MW). As the body's cardiac compensatory mechanisms act to maintain blood flow (cardiac output), the increased stress and metabolic impacts cause further cardiac enlargement and other detrimental changes. The onset of mitral valve regurgitation further reduces cardiac output and, thus accelerates the CHF process. Therefore, there is a need for a less invasive and traumatic way to treat mitral valve regurgitation (MVR).[0013]
SUMMARY
• The exemplary embodiments of the present invention disclose apparatuses and methods for treating a valve such as a defective heart valve. The exemplary embodiments of the present invention also disclose annuloplasty devices and delivery devices used to deliver/deploy the annuloplasty devices to treat such a valve.[0014]
• One exemplary embodiment pertains to a medical device that comprises a delivery sheath, an implantable device moveably disposed within the delivery sheath, and an actuator releasably coupling to the implantable device. The implantable device further comprises a distal expandable basket, a proximal expandable basket, and a connecting member coupling at a first end to the distal expandable basket and at a second end to the proximal expandable basket. The distal expandable basket and proximal expandable basket are deliverable in a compressed state and deployed to an expanded state. The actuator is used to facilitate the deployment of the implantable device.[0015]
• Another exemplary embodiment pertains to a method of deploying an implantable device in a blood vessel. The method comprises providing a medical device that comprises a delivery sheath, an implantable device moveably disposed within the delivery sheath, and an actuator releasably coupling to the implantable device. The implantable device comprises a distal expandable basket, a proximal expandable basket, and a connecting member coupling at a first end to the distal expandable basket and at a second end to the proximal expandable basket. The method further comprises deploying the implantable device into a blood vessel with the distal expandable basket and the proximal expandable basket in a collapsed state. When the distal expandable basket is in a proper position, the delivery sheath is withdrawn to allow the distal expandable basket to expand and rest against the inner wall of the blood vessel. The proximal expandable basket is then deployed while tension is applied to the actuator. Once the proximal expandable basket is pulled to a proper position along the blood vessel, the delivery sheath is withdrawn to allow the proximal expandable basket to expand to rest against the inner wall of the blood vessel. The implantable device is, after deployments of the distal expandable basket, proximal expandable basket, and the connecting member, capable of reshaping the blood vessel. In another embodiment, the blood vessel has a first curvature and when the implantable device is deployed, the implantable device changes the first curvature to a second curvature wherein the second curvature is smaller than the first curvature. The blood vessel may be a coronary sinus in one embodiment.[0016]
• The methods of treating mitral valve using the exemplary embodiments of the present invention are also disclosed and other exemplary embodiments are disclosed.[0017]
BRIEF DESCRIPTION OF THE DRAWINGS
• The present invention is illustrated by way of example and not limitation in the figures of the accompanying drawings, in which like references indicate similar elements and in which:[0018]
• FIG. 1A is an illustration of a heart;[0019]
• FIGS.[0020]1B-1C illustrate a normal mitral valve and an enlarged mitral valve, respectively;
• FIG. 1D is an illustration of an annuloplasty procedure to constrict a valve (e.g., a mitral valve);[0021]
• FIG. 1E is an illustration of a reconstruction procedure to reduce the size of a defective valve;[0022]
• FIG. 2A is an illustration of an exemplary embodiment of an annuloplasty device deployed within a coronary sinus;[0023]
• FIG. 2B is an illustration of how the annuloplasty device of FIG. 2A works to reduce the curvature of the coronary sinus and the mitral valve annulus;[0024]
• FIGS.[0025]2C-2D are illustrations of another exemplary embodiment of an annuloplasty device;
• FIG. 3A is an illustration a telescoping assembly that can be used for an annuloplasty device in accordance with the embodiments of the present invention;[0026]
• FIGS.[0027]3B-3C are illustrations of exemplary embodiments of mechanical interferences that can be used for an annuloplasty device in accordance with the present invention;
• FIGS.[0028]4-6 illustrate exemplary embodiments of force distribution members that can be used for an annuloplasty device in accordance with the embodiments of the present invention;
• FIGS.[0029]7-10 illustrate other exemplary embodiments of force distribution members that can be used for annuloplasty devices in accordance with the embodiments of the present invention;
• FIGS.[0030]11-14,15A-15B,16A-16D, and17-18 illustrate exemplary embodiments of distal anchoring members that can be used for annuloplasty devices in accordance with the embodiments of the present invention;
• FIGS.[0031]19A-19B,20,21A-21D, and22A-22B illustrate exemplary embodiments of proximal anchoring members that can be used for annuloplasty devices in accordance with the embodiments of the present invention;
• FIG. 23 is an illustration of an annuloplasty device disposed within a delivery device that can be delivered into a coronary sinus in accordance with the embodiments of the present invention;[0032]
• FIGS.[0033]24A-24B illustrate exemplary embodiments of position-locking devices that can be used for annuloplasty devices in accordance with the embodiments of the present invention;
• FIG. 25 is an illustration of an annuloplasty device disposed in a delivery device that can be delivered into a coronary sinus in accordance with the embodiments of the present invention;[0034]
• FIGS.[0035]26-28 illustrate another exemplary embodiment of a annuloplasty device in a delivery device that can be delivered into a coronary sinus in accordance with the embodiments of the present invention;
• FIG. 29 illustrates an exemplary annuloplasty device deployed within a coronary sinus having anchoring members attached to cardiac tissue proximate the coronary sinus to reduce the curvature of the mitral valve annulus;[0036]
• FIG. 30 is an illustration of an exemplary annuloplasty device in accordance with the present invention that can be deployed as shown in FIG. 29;[0037]
• FIGS.[0038]31-33 illustrate exemplary embodiments of a balloon system that can be used to deploy an expandable structure of an annuloplasty device in accordance with the present invention;
• FIGS.[0039]34-36 illustrate exemplary embodiments of an expandable structure of an annuloplasty device in accordance with the present invention;
• FIGS.[0040]37A-37C illustrate exemplary embodiments of the expandable structure shown in FIGS.34-36 with curvature;
• FIGS.[0041]38-39 illustrate exemplary embodiments of the expandable structure shown in FIGS.34-36 with curvature;
• FIG. 40 illustrates an exemplary embodiment of the expandable structure shown in FIGS.[0042]38-39 in a fully expanded state;
• FIG. 41 illustrates an exemplary embodiment of a backbone that can be used to form the curvature for the expandable structure;[0043]
• FIG. 42 illustrates an exemplary embodiment of a straightening device that can be used to temporarily straighten out the expandable structure during deployment;[0044]
• FIGS.[0045]43-45 illustrate a balloon system that can be used to deploy the expandable structure;
• FIGS.[0046]46-50 illustrate exemplary embodiments of an expandable structure that can be made to curve to one side;
• FIG. 51 illustrates an exemplary embodiment of a delivery device that can be used to deliver an exemplary annuloplasty device of the present invention;[0047]
• FIG. 52 illustrates an exemplary embodiment of an annuloplasty device of the present invention;[0048]
• FIG. 53 illustrates an exemplary embodiment of a delivery device that can be used to deliver an exemplary annuloplasty device of the present invention;[0049]
• FIGS.[0050]54A-54D illustrate how an exemplary annuloplasty device of the present invention can be deployed;
• FIGS.[0051]55A-55C illustrate an exemplary embodiment of an annuloplasty device in accordance with the present invention;
• FIGS.[0052]56-58 illustrate exemplary embodiments of a distal anchoring member and a proximal anchoring member that can be used for the annuloplasty device shown in FIGS.55A-55C;
• FIGS.[0053]59A-59D illustrate exemplary embodiments of a spring-like spine in various configurations that can be used for the annuloplasty device shown in FIGS.55A-55C;
• FIG. 60 illustrates an exemplary embodiment of an annuloplasty device comprising coiled anchoring members;[0054]
• FIGS.[0055]61A-61F illustrate exemplary embodiments of coiled anchoring members;
• FIGS.[0056]62A-62E illustrate an exemplary embodiment of an annuloplasty device having distal and proximal expandable baskets connected by a connecting member;
• FIG. 63 illustrates an exemplary embodiment of a connecting member to connect an actuator to the annuloplasty device shown in FIGS.[0057]62A-62D;
• FIG. 64 illustrates another exemplary embodiment of a connecting member to connect an actuator to the annuloplasty device shown in FIGS.[0058]62A-62D;
• FIGS.[0059]65A-65C illustrate exemplary embodiments of a distal or proximal expandable basket for the annuloplasty device shown in FIGS.62A-62D; and
• FIG. 66 illustrates the annuloplasty device shown in FIGS.[0060]62A-62D with a distal stop and a proximal lock.
DETAILED DESCRIPTION
• The exemplary embodiments of the present invention pertain to novel annuloplasty devices, delivery devices to deploy/deliver the annuloplasty devices, and methods of using these annuloplasty devices to treat medical conditions such as defective or faulty heart valves. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the present invention. It will be evident, however, to one skilled in the art, that the present invention may be practiced without these specific details. In other instances, specific apparatus structures and methods have not been described so as not to obscure the present invention. The following description and drawings are illustrative of the invention and are not to be construed as limiting the invention.[0061]
• In some exemplary embodiments of the present invention, an annuloplasty device used for treating a faulty heart valve such as those seen in MVR includes an annuloplasty device that reduces the cross-sectional size of the annulus of the mitral valve or brings the leaflets of the valves closer to each other. For example, the annuloplasty devices move the posterior annulus of the mitral valve toward the anterior annulus of the mitral valve. Alternatively, the annuloplasty device can reshape the cross-sectional size of the mitral valve annulus. Reshaping includes at least one of reducing, reforming, or adjusting the mitral valve annulus in ways that cause the leaflets of the mitral valve to move closer to each other. Reshaping may also include increasing the curvature (or reducing the radius along at least a portion of the curvature) of the coronary sinus that substantially encircles that mitral valve annulus thereby reshaping the mitral valve or the mitral valve annulus. Reshaping may also include decreasing the curvature (or increasing the radius along at least a portion of the curvature) of the coronary sinus in a way that exerts pressure on the mitral valve annulus or the mitral valve and flattening a portion or a side of the mitral valve annulus or the mitral valve.[0062]
• The term coronary sinus can also includes the coronary vein or great cardiac vein as the name changes as one goes further up in the coronary sinus.[0063]
• There are numerous different embodiments described below, which can perform at least one of these treatments. For example, a medical device that includes a first and a second anchoring member, in one embodiment, reshapes the mitral valve annulus from the first anchoring member to the second anchoring member due to the flexural properties (e.g., long term stiffness) of the device which causes the mitral valve annulus to be reshaped to conform to the shape of this medical device. In this embodiment, there is no tightening in the sense of a significant force applied along the longitudinal axis of the device, between the two anchoring members. This type of medical device may not require anchors attached to or included with the anchoring members (e.g., hooks, barbs, screws, corkscrews, helixes, coils, flanges, etc . . . ) to hold the anchoring members in place.[0064]
• In another embodiment, a medical device, which includes a first anchoring member, a second anchoring member, and a connection between the anchoring members, that reshapes the mitral valve annulus from anchoring member to anchoring member by the medical device being cinched (tightened) by a cord/cord and position-locking mechanism in the connection or having a fixed length cord or tube which connects the anchoring members and which is shorter than the existing (dilated) annulus. In this another embodiment, the medical device normally has a low or insignificant long-term flexural modulus (and thus it is moderately to highly flexible), and the medical device normally includes anchors such as hooks, barbs, or flanges, to name a few, to hold the anchoring members in place in order to resist the longitudinal cinching forces.[0065]
• In yet another embodiment, a medical device includes a first anchoring member and a second anchoring member, which are coupled together by a connection, such as a telescoping assembly or a bellow-like member. The connection, of this yet another embodiment, reshapes the mitral valve annulus from anchoring member to anchoring member due to its flexural properties (e.g., long-term stiffness), and the medical device also reshapes the mitral valve annulus due to its being cinched (tightened) by a cord/cord and position-locking mechanism. Anchors may be used or otherwise included in the anchoring members of this yet another embodiment to ensure that the anchoring members remain in place. However, it may possible to balance the long-term stiffness and tightening so that the anchors are not required.[0066]
• These different embodiments may be deployed percutaneously with a catheter device, which has a distal end having a preferred orientation (due to axial flexural modulus differences) in a curved conduit, such as the coronary sinus. The preferred orientation can be used to orient the medical device within the coronary sinus.[0067]
• FIG. 2A illustrates one embodiment in which an[0068]annuloplasty device200 is deployed within a coronary sinus (CS)208, which substantially encircles or is adjacent to amitral valve210. Throughout the disclosure, the terminology “coronary sinus” covers not only the coronary sinus such as theCS208 but also a proximate extension of the coronary sinus, (e.g., a near branch or flow that ends into the CS, the Great Cardiac Vein, or the Middle Cardiac Vein). An annuloplasty device includes at least a device that can reshape a blood vessel such as theCS208, the mitral valve, and/or the mitral valve annulus. An annuloplasty device can also be deployed or delivered in, near, at, or within theCS208 using methods such as percutaneous delivery or surgical installation.
• Although the discussion below emphasizes on the deployment of the[0069]annuloplasty device200 within the coronary sinus, theannuloplasty device200 can be deployed within another blood vessel, vein, or artery to treat a different medical condition without departing from the scope of the present invention. Throughout the discussion, various exemplary embodiments of theannuloplasty device200 can be understood to be deployable in theCS208.
• The[0070]annuloplasty device200 includes adistal anchoring member202, aproximal anchoring member204, and atelescoping assembly206 coupling to thedistal anchoring member202 and theproximal anchoring member204. Theannuloplasty device200 can be percutaneously delivered and/or deployed (e.g., through a catheter) into theCS208 through a blood vessel, a vein, or an artery, or alternatively, it may be delivered through a conventional surgical technique. Theannuloplasty device200 is capable of reshaping theCS208 and/or reducing the mitral valve annulus or the mitral valve that has been enlarged or is otherwise not properly sealed.
• Additionally, the[0071]annuloplasty device200 is capable of reshaping a ventricle (e.g., the left ventricle) that has been enlarged due to a faulty valve (e.g., mitral valve regurgitation or MVR). In some cases, MVR causes the left ventricle to enlarge causing the papillary muscles (not shown) to move away from themitral valve210 and the chordae (not shown) attached between the papillary muscles and the leaflets (not shown) of themitral valve210. This enlarged ventricle causes themitral valve210 to be held open (or referred to as “tethering”). Theannuloplasty device200 may reduces regurgitation by moving the posterior leaflet (not shown) nearer to the anterior leaflet (not shown) and prevents enlargement of themitral valve210.
• The[0072]distal anchoring member202 is configured to be deployed within theCS208 as shown in FIG. 2A. Upon deployment, (or after deployment is complete) at least a portion of thedistal anchoring member202 anchors or attaches to the inner wall of theCS208. Additionally, upon deployment, at least a portion of thedistal anchoring member202 may also penetrate the wall of theCS208 and may anchor or attach to a cardiac tissue (or myocardial tissue) proximate the portion of theCS208 where thedistal anchoring member202 is deployed. Thedistal anchoring member202 may be deployed in the great cardiac vein, which is an extension or part of theCS208. In one embodiment, at least a portion of thedistal anchoring member202 anchors or attaches to an area proximate the left trigone (not shown) adjacent themitral valve210 or to an annulus tissue. Portions of thedistal anchoring member202 may penetrate the wall of theCS208 and anchor to the left trigone, the annulus tissue, or the area proximate theCS208.
• The[0073]proximal anchoring member204 is configured to be disposed within or at theentrance216 of theCS208 as shown in FIG. 2A. Theentrance216 of the coronary sinus is the junction of the coronary sinus and the right atrium; in other words, this entrance is the point where deoxygenated blood from the heart enter the right atrium. At least a portion of theproximal anchoring member204 anchors or attaches to a cardiac tissue proximate another portion of theCS208 where theproximal anchoring member204 is deployed. For example, at least a portion of theproximal anchoring member204 anchors or attaches to an area at theentrance216 of theCS208. Alternatively, at least a portion of theproximal anchoring member204 anchors or attaches to an annulus tissue or a myocardial tissue near theentrance216 of theCS208.
• The[0074]telescoping assembly206 is deployable within theCS208. Thetelescoping assembly206 includes at least two members (e.g., tubes) wherein one is moveably (e.g., slidably) fitted within another. A telescoping assembly, in certain embodiments, is referred to as a member that includes at least two sections, such as two cylindrical tubes or sections that can slide/move inward and outward in an overlapping manner. In one embodiment, and as shown in FIG. 2A, thetelescoping assembly206 includes adistal tube212, acenter tube218, and aproximal tube214 wherein thedistal tube212 is coupled to thedistal anchoring member202 and theproximal tube214 is coupled to theproximal anchoring member204. Thetelescoping assembly206 is able to reduce the distance between thedistal anchoring member202 and theproximal anchoring member204 once theannuloplasty device200 is fully deployed by bringing thedistal tube212 and theproximal tube214 closer to each other (sometimes referred to as “telescoping”). For example, as shown in FIG. 2B, thedistal tube212 slides in thedirection213 into thecenter tube218. Likewise, theproximal tube214 slides in thedirection215 into thecenter tube218. As thedistal tube212 and theproximal tube214 slide into thecenter tube218, thetelescoping assembly206 becomes shorter.
• Reducing the distance between the[0075]distal anchoring member202 and the proximal anchoring member204 (after they are anchored in the coronary sinus) reduces or shortens portions of theCS208. Theannuloplasty device200 thus is able to reshape at least a portion of theCS208 thereby reshaping the cross-sectional size of theannulus209 of themitral valve210 that is substantially encircled by theCS208.
• Typically, the[0076]CS208 and theannulus209 of themitral valve210 near theCS208 are elastic in nature and are stretched by internal pressures generated by the heart. When thetelescoping assembly206 reduces/shortens the distance between thedistal anchoring member202 and theproximal anchoring member204, some portions of theCS208 and the annulus of themitral valve210 will be taken up as the pressure of thetelescoping assembly206 acts against the internal pressure and negates it. In some examples, the shortening of theCS208 returns the tissue of theCS208 to its “rest” dimensions (which is smaller than its “enlarged” dimension caused by a faulty mitral valve or MVR). As theCS208 shortens, theCS208 applies pressure on theannulus209 of themitral valve210 causing the posterior leaflet of themitral valve210 to be brought closer to the anterior leaflet effectively reducing or reshaping the cross-sectional size of theannulus209. As theCS208 shortens, theCS208 flattens and the curvature of theCS208 is reduced which causes theCS208 to flatten portions of theannulus209 of themitral valve210 as shown in FIG. 2B. Thus, the posterior leaflet of themitral valve210 is pushed toward the relatively fixed anterior leaflet. Since the posterior and anterior leaflets are moved closer together, the gap between them gets smaller or disappears and regurgitation is reduced or eliminated.
• In one embodiment, reducing the distance between the[0077]distal anchoring member202 and theproximal anchoring member204 increases the curvature radius (or decrease the curvature) along at least a portion of the curvature of themitral valve annulus209 as shown in FIG. 2B. In FIG. 2A, thetelescoping assembly206 has been deployed but has not acted to reduce the distance between thedistal anchoring member202 and theproximal anchoring member204; theCS208 has a curvature radius R₁. In FIG. 2B, thetelescoping assembly206 reduced or shortened the distance between thedistal anchoring member202 and theproximal anchoring member204; theCS208 now has a curvature radius R₂, which is larger than the curvature radius R₁.
• As can be seen, one reason for having the[0078]telescoping assembly206 is that thetelescoping assembly206 may comprise of at least two members (e.g., thedistal tube212 and the proximal tube214) wherein one smaller tube can slide into a larger tube. Thetelescoping assembly206 can reduce the distance between thedistal anchoring member202 and theproximal anchoring member204 with a telescoping action. Additionally, thetelescoping assembly206 can shorten a portion of theCS208 thereby reshaping and reducing the curvature of theCS208 and theannulus209 of themitral valve210.
• It will be appreciated that the[0079]telescoping assembly206 is not the only structure that performs the functions mentioned above. In one embodiment, thetelescoping assembly206 is replaced by a bellow-like member254 shown in FIGS.2C-2D. In this embodiment, the bellow-like member254 comprises a plurality ofpleats256, which allows that bellow-like member254 to be compressed and extended. In one embodiment, the bellow-like member254 is made of a shaped-memory material (e.g., Nitinol) such that during deployment, the bellow-like member254 can be extended as shown in FIG. 2D. The bellow-like member254 can also be made out of a polymer. The extended bellow-like member254 allows thedistal anchoring member202 and theproximal anchoring member204 to be deployed. Once deployment is complete, the bellow-like member254 is allowed to return to its original shape (unextended) as shown in FIG. 2C. In one embodiment, the bellow-like member254 is a tube having a bellow-like structure or wall. In one embodiment, a stiffening member (not shown) is disposed in the inner diameter or over the outer diameter of the bellow-like member254 to increase flexural modulus for the bellow-like member254.
• FIGS.[0080]3-10 illustrate various exemplary embodiments of a telescoping assembly that can be used for thetelescoping assembly206. FIGS.11-18 illustrate various exemplary embodiments of the distal anchoring member that can be used for thedistal anchoring member202. FIGS.19-22 illustrate various exemplary embodiments of the proximal anchoring member that can be used for theproximal anchoring member204.
• FIG. 3A illustrates an exemplary embodiment of a[0081]telescoping assembly220 that can be used for thetelescoping assembly206 of theannuloplasty device200 shown in FIGS.2A-2B. Thetelescoping assembly220 includes adistal tube228, acenter tube226, and aproximal tube230. It is to be understood that in alternative embodiments, only two tubes are necessary or more than three tubes can be used. In one embodiment, each of thedistal tube228, thecenter tube226, and theproximal tube230 is made of a flexible material. Thedistal tube228, thecenter tube226, and theproximal tube230 are dimensioned such that thedistal tube228 is slidably fitted inside thecenter tube226 from one end of thecenter tube226 and theproximal tube230 is slidably fitted inside thecenter tube226 from the other end of thecenter tube226. In one embodiment, thedistal tube228 and theproximal tube230 can slide into thecenter tube226. In an alternative embodiment, thecenter tube226 may be slidably fitted inside thedistal tube228 or theproximal tube230 or both. Thecenter tube226 thus slides into thedistal tube228, theproximal tube230, or both.
• Each of the[0082]distal tube228, thecenter tube226, and theproximal tube230 may have any suitable cross-sectional shape. For example, the tubes may be circular, oval, or rectangular in cross-section. The chosen shape should be one that provides that most surface area for thetelescoping assembly220 to be deployed against the wall of theCS208 without a substantial blockage of the flow (to prevent stenosis and clotting) within theCS208.
• The[0083]distal tube228 further includes a bent portion such as aU-shaped portion232 that is relatively stiff. TheU-shaped portion232 is useful when theannuloplasty device200 needs to be positioned over an area that has other artery or blood vessel crossing below. In one embodiment, theU-shaped portion232 is useful when theannuloplasty device200 needs to be placed over the circumflex coronary artery. TheU-shaped portion232 allows the annuloplasty device to avoid compressing the circumflex coronary artery when theannuloplasty device200 is in position and fully deployed. In one embodiment, theU-shaped portion232 is made of a flexible material. Other bent portions having other shapes (e.g., an S-shape or a V-shape) may be used instead of the U-shaped.
• In one embodiment, the[0084]U-shaped portion232 may include a telescoping feature similar to thetelescoping assembly220. Thus, theU-shaped portion232 itself may include at least two members or tubes that can slide inward or outward into each other.
• In one embodiment, at least one[0085]cord224 is disposed through the inner diameters of thetelescoping assembly220. Thecord224 functions to adjust the length of thetelescoping assembly220. In one embodiment, thecord224 couples to the distal end portion231 of theU-shaped portion232 and extending from theU-shaped portion232 through theproximal tube230. Thecord224 could also be coupled to any portion of the distal tube225 or any portion of thetelescoping assembly220. The distal end of thecord224 may also attach to or engage with a distal anchoring device (not shown) such as thedistal anchoring member202 shown in FIG. 2A. The proximal end of thecord224 attaches to or engages with a proximal anchoring device (not shown) such as theproximal anchoring member204 shown in FIG. 2B. When thecord224 is pulled proximally relative to the proximal tube230 (or the proximal anchoring member), thecord224 is placed in tension, causing thedistal tube228 and theproximal tube230 to move closer together and telescope into thecenter tube226. Alternatively, when thecord224 is pulled distally relative to the distal tube228 (or the U-shaped portion232), thecord224 is placed in tension, causing thedistal tube228 and theproximal tube230 to move closer together and telescope into thecenter tube226.
• The[0086]cord224 can be made of metal, metal alloy, NiTi, Nitinol, and etc. Thecord224 can be made of an elastic material such as silicone/silastic, nitrile, polyurethane, neoprene, and fluorosilicone, and etc. Thecord224 can be made out of or coated with a low friction material, like a fluorocarbon, Acetal, PE, or Nylon. Thecord224 may have any suitable cross-sectional shape, rectangular, circular, oval, etc.
• In one embodiment, the[0087]distal tube228, theproximal tube230 and thecenter tube226 contain mechanical interferences such that thedistal tube228 will not disengage from the inner diameter of thecenter tube226 and theproximal tube230 will not disengage from the inner diameter of thecenter tube226. Examples of suitable mechanical interferences include o-rings, lips, flanges pins, projections, or slots created into or attached to the tubes.
• In one embodiment, a suitable mechanical interference includes a flange/[0088]lip type interference370 as shown in FIG. 3B. In this embodiment, thedistal tube228 includes lips/flanges372 and thecenter tube226 includes lips/flanges374. The lips/flanges372 and374 engage each other to prevent disengagement as thedistal tube228 and thecenter tube226 slide into and away from each other. Thesame interference370 can be used to apply to other tubes of thetelescoping assembly220, for example, theproximal tube230 could also include thesame interference370.
• In one embodiment, a suitable mechanical interference includes a pin/projection type interference[0089]371 as shown in FIG. 3C. In this embodiment, thedistal tube228 includes at least one pin/projection376, which engages at least oneslot378 created into thecenter tube226 to prevent the distal tube223 from disengaging theproximal tube226. The same interference371 can be used to apply to other tubes of thetelescoping assembly220, for example, theproximal tube230 could also include thesame interference370.
• In one embodiment, the distal tube[0090]228 (including the U-shaped portion232), theproximal tube230 and thecenter tube226 are made of a low friction material, like a fluorocarbon, Acetal, PE or Nylon to limit the friction (for example, to make the telescoping action easier).
• In another embodiment, to prevent disengagement of the tubes of the[0091]telescoping assembly220, an extension-limiting cord (not shown) is disposed within or through the inner diameters of each of thedistal tube228, theproximal tube230, and thecenter tube226. The extension-limiting cord is attached between adjacent tubes. For example, one portion of the extension-limiting cord is attached to both thedistal tube228 and thecenter tube226 and another portion of the extension-limiting cord is attached to both theproximal tube230 and thecenter tube226. The extension-limiting cord can be divided into two extension-limiting cords wherein one extension-limiting cord is attached to thedistal tube228 and thecenter tube226 at each end of the cord; and, the other extension-limiting cord is attached to theproximal tube230 and thecenter tube226 at each end of the cord. The length of the extension-limiting cord(s) is fixed such that if one adjacent tube is moved away from another adjacent tube, the extension-limiting cord dictates the maximum length or distance that the tubes can move away from each other. The extension-limiting cord(s) has a length that prevents the distal anchoring member and the proximal anchoring member from disengaging with thecenter tube226. The extension-limiting cord may be made out of a thin and flexible material such as nylon, Vectran® (Vectran® is a registered trademark of Hoechst Celanese and is manufactured by companies such as Dupont and Allied Signal), Kevlar® (Kevlar® is a registered trademark of Dupont and is manufactured by Dupont), or other suitable materials. One advantage of using the extension-limiting cord is that the various tubes of thetelescoping assembly220 can have smaller inner diameters which overall, allows for smaller annuloplasty devices.
• In one embodiment, the[0092]distal tube228 and theproximal tube230 are biased to be a predetermined distance (a minimum distance) away from each other during delivery/deployment. A compression spring(s) (not shown) may be placed inside the inner diameter of thecenter tube226 to bias the ends of thedistal tube228 and theproximal tube230. During delivery/deployment, the compression springs keep thedistal tube228 and theproximal tube230 apart. In some embodiments, the compression springs keep thedistal anchoring member228 and theproximal anchoring member230 from disengaging from thecenter tube226. Additionally, in some embodiments, the compressions springs may act to keep thedistal tube228 engaging to a least a portion of the distal anchoring member (not shown) and theproximal tube230 engaging to at least a portion of the proximal anchoring member (not shown).
• In one embodiment, the[0093]telescoping assembly220 has differential stiffness along the various sections and tubes of thetelescoping assembly220. One advantage for the differential stiffness is that it allows the annuloplasty device to have orientation, curve, and shape that make reshaping the-mitral valve annulus209 easier. A section that has a high stiffness is sometimes referred to as having a high flexural modulus. A section that has a low stiffness is sometimes referred to as having a low flexural modulus. Each of thedistal tube228, theproximal tube230, and thecenter tube226 may have variable flexural modulus. The flexural modulus of various tubes of thetelescoping assembly220 has a pronounced effect on the amount of tension or force that is required to be applied to thecord224 to adjust the length and/or curvature of themitral valve annulus209. For instance, very low flexural modulus (low stiffness) tubes makes device delivery easier, but will require a higher tension be applied to thecord224 to reform the mitral annulus such that the leaflets will coaptate (or close) reliably and eliminate mitral valve regurgitation. Very high modulus (high stiffness) tubes makes device delivery difficult, but will require a much lower tension to be applied to thecord224 to reform the mitral annulus such that the leaflets will coaptate (or close) reliably and eliminate mitral valve regurgitation.
• In one embodiment, the flexural modulus is optimized such that delivery of the annuloplasty device that contains the[0094]telescoping assembly220 is relatively or sufficiently easy while not too high of a tension is needed to change the length of thetelescoping assembly220. In one embodiment, thedistal tube228, thecenter tube226, and theproximal tube230 are made of low flexural modulus materials. The sections that thedistal tube228 and thecenter tube226 overlap are maximized. Likewise, the sections that theproximal tube230 and thecenter tube226 overlap are also maximized. When the annuloplasty device is being deployed or delivered, thedistal tube228, thecenter tube226, and theproximal tube230 are at the farthest extension, which gives thetelescoping assembly220 an overall low flexural modulus characteristic, which eases the delivery/deployment process. Once fully deployed, thedistal tube228 and theproximal tube230 are telescoped together (or retracted) into thecenter tube226 as close as possible to give thetelescoping assembly220 the most overlapping sections and to also shorten the length of thetelescoping assembly220. Thetelescoping assembly220 thus will have a high flexural modulus characteristic. Thus, a lower tension is required to be exerted on thecord224, which is used to reshape themitral valve annulus209.
• In one embodiment, each of the[0095]distal tube228, thecenter tube226, and theproximal tube230 itself has sections with variable flexural modulus or stiffness. The variable flexural modulus in each of the tubes further enhance the ease of adjusting, reducing, reforming, or reshaping themitral valve annulus209. Methods to provide differential or variable modulus to a structure are well known in the art.
• In one embodiment, the[0096]telescoping assembly220 includes at least one force distribution member. FIGS.4-6 illustrate cross-sectional views of exemplary configurations offorce distribution members240 and250, which can be incorporated into thetelescoping assembly220. As shown in FIG. 4, in one embodiment, a portion of theforce distribution member240 is coupled to the side of thetelescoping assembly220 that contacts the blood vessel (e.g., the CS208). Theforce distribution member240 may be a solid structure as shown in FIG. 4 or may include alumen251 as shown in theforce distribution member250 of FIGS.5-6. Thetelescoping assembly220 may be placed outside of thelumen251 as shown in FIG. 5 or inside of thelumen251 as shown in FIG. 6.
• The[0097]force distribution members240 and250 allow the use of a minimum sized circular cross-section for thetelescoping assembly220. A minimum size cross-section for thetelescoping assembly220 causes less interference with the flow or the blood flow in the blood vessel. Without the force distribution members, the outer diameter of thetelescoping assembly220 needs to be larger so as to not allow the force or tension of thecord224 to cut through the blood vessel that the annuloplasty device is deployed within. The force distribution members provide a large surface area to distribute the force exerted on the blood vessel by thetelescoping assembly220 and/or thecord224 over the blood vessel wall (or the wall of the CS208) preventing damage to the blood vessel wall that may be caused by a high and/or focused force applied on the wall.
• In one embodiment, the[0098]force distribution members240 and250 may include support members (such as a stiffening skeleton, struts, braid(s), flattened coil(s), etc.) as a part of their structure and/or be made of a variable thickness and/or width materials to facilitate the more even distribution of the force over the surface of the vein, as is well know to those skilled in the art. The force distribution members may have variable flexural modulus along each force distribution member or among one another. The force distribution members may also have variable dimensions (e.g., lengths and widths). Each of the force distribution members may be made of different material or design type.
• If desired, a force distribution member may cover a large section or the[0099]entire telescoping assembly220. In one embodiment, at least a portion of thetelescoping assembly220 is covered by a largeforce distribution member234 as shown in FIG. 7. Alternatively, various portions along thetelescoping assembly220 are covered by severalforce distribution members236 and238 as shown in FIG. 8. Theforce distribution members236 and238 may cover portions or theentire telescoping assembly220 with gaps between each distribution member. Alternatively, thetelescoping assembly220 may be covered with severalforce distribution members242,244, and246 with sections of force distribution members overlapping one another. Additionally, when the distribution members contain lumens, one distribution member may slide into another distribution member (as shown in FIG. 9) in the same manner that the various tubes of the telescoping assembly slide into one another. Adjacentforce distribution members242,244, or246 may slide over or inside one another. The force distribution members may have an oblong shape as shown in FIG. 7, a rectangular shape as shown in FIGS.8-9, or a circular shape as shown in FIG. 10.
• In one embodiment, the force distribution members (e.g., the[0100]force distribution members240,250,234,236,238,242, and244) may have projections or anchors (not shown). These projections or the anchors may engage adjacent force distribution members and function to control or adjust the length of thetelescoping assembly220. For instance, when thetelescoping assembly220 is replaced by the bellow-like member254 as shown in FIGS.2C-2D, the force distribution members control the extension of the bellow-like tube254 to a predetermined length. The projections or anchors may also aid (or even replace) the various tubes of thetelescoping assembly220 when necessary. For example, the force distribution members with anchors may allow replacing thetelescoping assembly220 with a single member/tube with no telescoping capability. These projections or anchors may face the wall of the blood vessel and may provide engagement with the blood vessel wall in a manner that causes length changes to be directed to a desired portion of the blood vessel wall. The projections or anchors may aid in the anchoring of the annuloplasty device that contains thetelescoping assembly220. The projections or anchors may also aid in the anchoring of thedistal anchoring member202 and theproximal anchoring member204.
• FIGS.[0101]11-18 illustrate exemplary embodiments of a distal anchoring member that can be used for thedistal anchoring member202 shown in FIGS.2A-2B. The distal anchoring members described below can be deployed into theCS208. The distal anchoring members may be deployed percutaneously using conventional delivery device or a delivery device that will be described below (e.g., FIGS. 23, 25, and26).
• FIG. 11 illustrates a side view of an exemplary[0102]distal anchoring member302. Thedistal anchoring member302 may have conventional stent designs or configurations typically used for cardiac related treatment such as angioplasty or carotid stenting. Thus, thedistal anchoring member32 may resemble a tube like cylinder which is hollow. An example of such a stent includes an AccuLink™ self-expending stent made by Guidant Corporation). Thedistal anchoring member302 is expandable and may or may not be self-expandable.
• In one embodiment, the[0103]distal anchoring member302 is self-expandable and may be made of a shaped-memory material such that upon deployment, thedistal anchoring member302 returns or expands back to its original shape and size as allowed by the blood vessel that it is placed in (e.g., the CS208). Examples of a shaped-memory material suitable for thedistal anchoring member302 include Nitinol or other material that has a memory of their original shapes. In one embodiment, thedistal anchoring member302 is made of a superelastic material such as Nickel Titanium alloys, CuZnAl alloys, CuAlNi alloys, FeMnSi alloys, InTi alloy, MnCu alloys, AgCd alloys, AuCd alloys, etc . . . .
• Alternatively, the[0104]distal anchoring member302 may be expanded by mechanisms well known in the art, for example, by an inflatable or dilatable balloon. Thedistal anchoring member302 is sized to fit within the blood vessel that it is being deployed within. In one embodiment, thedistal anchoring member302 is sized to fit within a coronary sinus or a great cardiac vein, such as theCS208 shown in FIGS.2A-2B. In one embodiment, once fully deployed within theCS208, thedistal anchoring member302 is deployed against the inner wall of theCS208. In one embodiment, thedistal anchoring member302 is deployed such that its outer wall (outer diameter) presses against the inner wall (inner diameter) of theCS208.
• FIG. 12 illustrates a side view of an exemplary[0105]distal anchoring member402. Thedistal anchoring member402 is similar to thedistal anchoring member302 shown in FIG. 11 except that thedistal anchoring member402 includes a plurality of projections or anchors403. Theanchors403 may be configured to shape like, helixes, coils, hooks, barbs, corkscrews, screws, flanges, or any other suitable anchoring device. Theanchors403 are designed to penetrate the wall of theCS208 and attach or anchor to a cardiac tissue proximate theCS208. In one embodiment, theanchors403 penetrate the wall of theCS208 and anchor into the left trigone proximate theCS208. Theanchors403 thus provide additional support for thedistal anchoring member402 to allow a secure deployment of thedistal anchoring member402 within theCS208 at a particular location along theCS208. Theanchors403 may have shape or arcs that are suitable for definitive anchoring of thedistal anchoring member402.
• FIG. 13 illustrates a side view of an exemplary[0106]distal anchoring member502 which is similar to thedistal anchoring member402 except that a plurality of projections or anchors503 are distributed over the outer diameter of thedistal anchoring member502. Theanchors503 can be the same as theanchors403 described above. The addition of more anchors improves the anchoring capability of thedistal anchoring member502. Theanchors503 may be distributed over the outer diameter of thedistal anchoring member502 in any convenient manner, location, and number.
• FIG. 14 illustrates a side view of an exemplary[0107]distal anchoring member602, which is similar to thedistal anchoring member402 except that the anchors have barbed shapes, as illustrated byanchors603. Additionally, theanchors603 are also distributed along one side of thedistal anchoring member602. In some applications, the distal anchoring member needs to be anchored only on one side. For example, when thedistal anchoring member602 is deployed within theCS208, thedistal anchoring member602 needs to penetrate only one side of theCS208 to be anchored to an area in the left trigone, an area proximate theCS208, or in the annulus tissue of themitral valve210 that is adjacent theCS208. Thus, it is only necessary to distribute theanchors603 only on the side of thedistal anchoring member602 that will be the anchoring side.
• FIGS.[0108]15A-15B illustrate sectional views of an exemplarydistal anchoring member702. FIG. 15A is a side view and FIG. 15B is a cross-sectional view. Thedistal anchoring member702 is similar to thedistal anchoring member602. Thedistal anchoring member702 includes a plurality of projections or anchors703 distributed and oriented toward one side of thedistal anchoring member702. In one embodiment, the anchor support relies on theanchors703 that penetrate the cardiac tissue, the annulus tissue, or the left trigone through the wall of theCS208. Theanchors703 may be required only on one side of thedistal anchoring member702. In one embodiment, a proper orientation may be necessary such that theanchors703 are oriented toward the anchoring site. This will required that thedistal anchoring member702 be properly oriented within the coronary sinus.
• In one embodiment, the[0109]distal anchoring member702 is composed of differential stiffness (variable flexural modulus). Theside705 of thedistal anchoring member702 that does not include anyanchors703 is made stiffer than theside707 of thedistal anchoring member702 that includes theanchors703. In one embodiment thedistal anchoring member702 is deployed within theCS208, which curves around themitral valve210 shown in FIGS.2A-2B. Thedistal anchoring member702 also curves during and after its deployment within theCS208. The lowest storage energy state of thedistal anchoring member702 is with thestiffer side705 toward the outside of acurved CS208. In other orientations of higher energy storage, the produced energy gradient tends to twist thedistal anchoring member702 and the delivery device/catheter used to deliver thedistal anchoring member702 toward the lowest energy state which directs thedistal anchoring member702 toward the desired anchoring site/orientation (e.g., the mitral valves annulus tissue, the myocardium, and the left trigone) and away from the free wall of theCS208 or other less desirable anchor orientations. In one embodiment, the variable flexural modulus of thedistal anchoring member702 is provided by adding more material and/or a pattern on theside705 than theside707 such that theside705 has a higher flexural modulus. Suitable patterns that will provide a higher flexural modulus to thedistal anchoring member702 are well known and understood by those skilled in the art.
• In one embodiment, the[0110]distal anchoring member702 is deployed within theCS208 using a delivery catheter. At least a portion of the delivery catheter's distal end, proximate to thedistal anchoring member702 has a higher flexural modulus on one side than the other. Thus, when the delivery catheter is inserted into acurved CS208, its lowest energy storage state will be with the higher flexural modulus side toward the outside of the blood vessel's curve. In other orientations of higher energy storage, the produced energy gradient tends to twist the delivery device toward the orientation of the lowest energy state. The orientation for thedistal anchoring member702 is controlled by the orientation of the delivery catheter. Thus, mounting thedistal anchoring member702 in or on the delivery catheter in a controlled orientation relative to the delivery catheter's higher flexural modulus side directs the distal anchoring member (as previously described) or other features of thedistal anchoring member702 toward the desired anchoring site/orientation (e.g., the mitral valves annulus tissue, the myocardium, and the left trigone) and away from the free wall of theCS208 or other less desirable anchor orientations.
• FIGS.[0111]16A-16D illustrates a cross section of adistal anchoring member802 that comprise of anouter part805 and aninner part822. It is to be appreciated that the configuration of thedistal anchoring member802 can be applied to other anchoring members that include at least one projection or anchor. Theouter part805 can be a protective sheath that is disposed outside of theinner part822 that has a plurality ofanchors803. Alternatively, theouter part805 can be the distal anchoring member itself while theinner part822 is the structure that includes theanchors803. In one embodiment, theouter part805 is a stent-like device that is expandable and/or self-expandable. Theouter part805 includes a plurality of openings (e.g., holes or slots)812 cut into it. During deployment, theouter part805 keeps theanchors803 in a non-deployed position (non-projecting or non-anchoring position). Theouter part805 prevents theanchors803 from damaging the wall of the blood vessel as thedistal anchoring member802 is being deployed. When thedistal anchoring member802 is being deployed, theanchors803 are contained/constrained by theouter part805. Once thedistal anchoring member802 reaches the proper location for deployment and anchoring, theouter part805 is slightly moved away from theinner part822 such that the end of theanchors803 engage or can be made to engage theopenings812. Once theanchors803 pass through theopenings812, theanchors803 project out and penetrate the wall of the blood vessel and anchor themselves into a myocardium tissue proximate the blood vessel (e.g., the left trigone or the mitral valve annulus tissue). After deployment, theanchors803 anchor thedistal anchoring member802 into the blood vessel.
• FIGS.[0112]17-18 illustrate a sectional view of adistal anchoring member902. Thedistal anchoring member902 is similar to those distal anchoring members described above with an addition of atension cord906 attaching to thedistal anchoring member902. Thetension cord906 may include a plurality ofbranches908 each of which is attached to a point at thedistal end910 of thedistal anchoring member902. In one embodiment, thetension cord906 extends along thedistal anchoring member902 and through the telescoping assembly (not shown) that is coupled to thedistal anchoring member902. Thetension cord906 can also act as thecord224 to telescope the various tubes of the telescoping assembly such as thetelescoping assembly220 while exerting compression forces on thedistal anchoring member902.
• In one embodiment, the[0113]distal anchoring member902 is configured so that a compression force caused by thetension cord906 expands the outer diameter of thedistal anchoring member902. For example, when thetension cord906 is pulled in the direction D₁, the outer diameter of thedistal anchoring member902 increases from the OD₁to OD₂wherein OD₂>OD₁. Enlargement of the outer diameter helps ensure that thedistal anchoring member902 is securely deployed against the inner diameter of theCS208. When tension is applied to thetension cord906 proximally, the length of thedistal anchoring member902 is decreased from length L₁to length L₂. In one embodiment, thetension cord906 is the same as thecord224 used to adjust the length of thetelescoping assembly220 described above. The tension longitudinally compresses thedistal anchoring member902 to the shorter length L₂thereby making the outer diameter of thedistal anchoring member902 larger. Thetension cord906 ensures an increased pressure of thedistal anchoring member902 against the blood vessel. This increased pressure causes thedistal anchoring member902 positioned in the blood vessel to be better retained at its deployment location. The configuration of thedistal anchoring member902 is especially useful when the distal anchoring member does not include a projection or an anchor. Although not shown, thedistal anchoring member902 may also include anchors (e.g., hooks, barbs, or screws) for better attachment.
• In one embodiment, any of the distal anchoring members described may incorporate materials/coatings/drugs that encourage their attachment or biological incorporation into the cardiac tissue to prevent displacement of the distal anchoring members. Additionally, any of the distal anchoring members described may incorporate coatings/materials/drugs that help keep the inner diameter of the[0114]CS208 clear and open.
• FIGS.[0115]19-23 illustrate sectional views of exemplary embodiments of a proximal anchoring member that can be used for theproximal anchoring member204 shown in FIGS.2A-2B. It will be appreciated that the proximal anchoring member may have the configurations of any of the distal anchoring members previously described as alternatives to the configurations in FIGS.19-23 described below.
• FIGS.[0116]19A-19B illustrate an exemplaryproximal anchoring member304. FIG. 19A is a side view of a proximal anchoring member, and FIG. 19B is a view from the distal end of the proximal anchoring member. The dimensions and shapes of theproximal anchoring member304 may be varied and corners/sharp edges may be blended or radiused as necessary. In one embodiment, theproximal anchoring member304 comprises adistal portion308 and aflange portion306. In one embodiment, theproximal anchoring member304 is deployed in theentrance216 to the CS208 (shown in FIGS.2A-2B). Thedistal portion308 is deployed inside theCS208 and theflange portion306 is deployed outside the CS208 (e.g., near the junction of theCS208 and the right atrium) such that it prevents theproximal anchoring member304 from being displaced distally within theCS208 as a result of forces applied to theproximal anchoring member304 by the telescoping assembly such as thetelescoping assembly206 shown in FIGS.2A-2B or thetelescoping assembly220 shown in FIG. 3A. In some embodiments, thedistal portion308 may be very short or omitted entirely, but this is not recommended, as the danger of blocking flow from theCS208 may be increased. Thedistal portion308 may be made similar to the distal anchoring members previously described. Thedistal portion308 may include anchors (not shown) such that upon deployment, the anchors attach to the wall of theCS208. Thedistal portion308 is expandable or self-expandable similar to the distal anchoring member previously described. Thedistal portion308 is sized so that its outer diameter engages the inner diameter of theCS208 in order to prevent blocking to a venous flow path. Thedistal portion308 may incorporate drugs, coatings, or materials that help keep the entrance to the CS clear and open.
• In one embodiment, the[0117]flange portion306 engages the right atrium (RA) wall (not shown). In one embodiment, theflange portion306 is circular (but need not be circular) as shown in FIG. 19A. Theflange portion306 may have its shape modified to avoid interference with the function of the Tricuspid valve (not shown) or to concentrate support to the regions of the right atrium that is in closer proximity to the right trigone (not shown). Theflange portion306 is expandable or self-expandable. Theflange portion306 may incorporate features (e.g., anchors, hooks, barbs, or screws, etc.), materials, coatings, or drugs that encourage its attachment or biologic incorporation into the right atrium wall. Theflange portion306 may also be made of a porous material, a reinforced porous material, coated with a porous material and/or drug coated to encourage its incorporation into the right atrium wall. In one embodiment, theflange portion306 is collapsible such that during deployment, the flange portion is folded to fit within the delivery device and after deployment, theflange portion306 expands to engage and remain at or just proximal to the entrance of theCS208. In one embodiment, theflange portion306 may be discontinuous and/or formed to appear as two or more separate arms or bands.
• In one embodiment, as shown in FIG. 20, the[0118]flange portion306 may be formed of a plurality ofarms408 that upon deployment, thearms408 spring out to form a globe-like structure that prevents theproximal anchoring member304 from being displaced distally within theCS208 as a result of forces applied to theproximal anchoring member304 by the telescoping assembly such as thetelescoping assembly206 shown in FIGS.2A-2B or thetelescoping assembly220 shown in FIG. 3A. Thearms408 may have the shapes of curved bands. The multiple curved bands are joined to each other at two points or to tworings410 and412 to form the globe-like structure that is sufficiently large so as to not be able to enter theCS208. Thering410 may replace thedistal portion308 of theproximal anchoring member304 or may be attached to the distal portion308 (not shown here).
• The number of the[0119]arms408 may be any desired number, but a number greater than 2 provides the most stable form for theflange portion306. Thearms408 may have a rest shape (or a natural shape) that is curved. This curve need not be circular as shown in FIG. 20, but may have some curve that is convenient for the control of the collapsing and the expansion of theflange portion306. The curve orientation of thearms408 may be as shown in FIG. 20 in which thearms408 have concave sides toward one another. The curve orientation of thearms408 may have other forms, for example, convex forms or the combination of convex and concave forms.
• In one embodiment, the[0120]arms408 have spiral forms (not shown). In this configuration, when thearms408 are confined inside a tube (for delivery), thearms304 form a spring-like configuration that is very flexible. The spiraledarms408 also increase the ease of delivery.
• FIGS.[0121]21A-21D illustrate an exemplary embodiment of aproximal anchoring member309 that includes a plurality of anchors, anchors503 and anchors501. In one embodiment, theproximal anchoring member309 resides upon the right atrium wall and near or at the right trigone. Theanchors501 and503 enable theproximal anchoring member309 to penetrate the right atrium and engage the right trigone or the area near the right trigone. Theanchors501 and503 also enable aflange portion346 of theproximal anchoring member309 to anchor to the entrance of theCS208. The anchors may be helixes, coils, hooks, barbs, screws, rivets, flanges, or corkscrews as some are shown in FIGS.21A-21D.
• The[0122]proximal anchoring member309 also includestelescoping members347 and348, which can slide into each other, or telescope together as shown in FIGS.21A-21B where thetelescoping member347 slides into thetelescoping member348. Thetelescoping members347 and348 function much like thetelescoping assembly220 previously described. Theanchors501 are attached to thetelescoping member347 and are biased by their rest configuration (curvature) and/or the manner in which their ends are sharpened. Theanchors501 are curved at rest and are constrained within the inner diameter of thetelescoping member348, such that they begin their deployment in a relatively straighter or less curved condition. Thetelescoping member347 contains amechanical interference349 that engages with the telescoping member348 (much similar to previously described) such that the deployment of theanchors501 is limited to a predetermined length (telescoping length) and that thetelescoping member347 will not disengage from thetelescoping member348. When deployed, theanchors501 penetrate or attach to the right trigone.
• The[0123]telescoping section348 is attached to aflange346. Theflange346 contains an opening (not shown) to allow theanchors501 to pass through for deployment. Theflange346 includes theanchors503 on the side of theflange346 that contacts the right atrium. Theflange346 distributes the forces applied toproximal anchoring member309 over an area of the right atrium during the deployment of theanchors503. Theflange346 may be configured to have a wide variety of shapes (oval or flat). Theflange346 may have a shape that facilitates the delivery of theproximal anchoring member309 to the right atrium wall. Theflange346 may be made of a porous material, a reinforced porous material, coated with a porous material and/or drug coated to encourage its incorporation into the right atrium wall.
• Additionally, the[0124]anchors501 and theanchors503 may be made of or coated with a porous material and/or drugs to encourage their incorporation into adjacent tissue. Further yet, theproximal anchoring member309 may include radiopaque marker(s) in any of its portion to aid in the delivery visualization and in orienting of theproximal anchoring member309 such that theanchors503 and501 point toward the side of theCS208 that faces themitral valve annulus209.
• The[0125]proximal anchoring member309 can be used as theproximal anchoring member204 of theannuloplasty device200. Theproximal anchor member204 may be attached or coupled to thetelescoping assembly220 previously described.
• FIGS.[0126]22A-22B illustrate aproximal anchoring member307 that can be used for theproximal anchoring member204 shown in FIGS.2A-2B. Theproximal anchoring member307 is similar to theproximal anchoring member304 previously described except that theflange portion306 of theproximal anchoring member304 is now replaced with anarm316 that includes a plurality ofanchors503. Theproximal anchoring member307 includes adistal tube308 similar to theproximal anchoring member304. Theanchors503 are useful when it is necessary to penetrate the right trigone to gain desired support levels to provide an effective therapy. In some cases, it is desired that the locations of anyanchors503 that are directed to the right trigone be controlled. Controlling the length of thearm316 controls the placement of theanchors503. The desired length of thearm316 may be determined dependant upon the distance from theentrance216 of theCS208 to the right trigone. The distance from theentrance216 of theCS208 to the right trigone may be obtained using conventional methods such as TEE (Transesophageal Echo) and TTE (Transthoracic Echo). Theproximal anchoring member307 with thearms316 may be provided with thearms316 having various lengths to accommodate anatomy/disease state variations. In one embodiment, theproximal anchoring member307 comprises at least one radiopaque marker to aid in the orientation/placement of thearm316. Thearm316 and thedistal portion308 can be coated with materials, coatings, or drugs that encourage the incorporation or anchoring of theproximal anchoring member307.
• FIGS.[0127]23-28 illustrate cross-sectional views of exemplary embodiments of delivery devices that can be used to deliver and deploy a telescoping assembly (e.g., the telescoping assembly220), a distal anchoring member (e.g., the distal anchoring member302), and a proximal anchoring member (e.g., the proximal anchoring member304) that can be used to treat mitral valve regurgitation.
• FIG. 23 illustrates an exemplary medical device[0128]200A that can be used to treat mitral valve regurgitation. Although the discussion below focuses on treating mitral valve regurgitation, the medical device200A can be used to treat other conditions that require reforming, reshaping, or reducing a blood vessel. The medical device200A comprises anannuloplasty device201 and adelivery device203. Theannuloplasty device201 is deployed near, at, in, or within theCS208 while thedelivery device203 is used to deliver theannuloplasty device201 to theCS208.
• In one embodiment, the[0129]annuloplasty device201 of the medical device200A comprises adistal tube100, aproximal tube101, adistal anchoring member102, aproximal anchoring member103, a position-lockingdevice104, a cord assembly105 (only a portion of which is visible) and adetaching mechanism106.
• The[0130]delivery device203 of the medical device200A comprises an outer sheath107, aninner sheath108, an atraumaticdistal tip110, aninner shaft109, and aguidewire lumen111. In one embodiment, theouter sheath102 includes the atraumaticdistal tip110 and theguidewire lumen111.
• The[0131]delivery device203 is used to introduce theannuloplasty device201 to the treatment site. Thedelivery device203 is withdrawn after thedistal tube100, theproximal tube101, thedistal anchoring member102, and theproximal anchoring member103 are deployed. Note that the outer sheath107, theinner sheath108, theinner shaft109, and thedetaching mechanism106 are shown in sectional side view in FIG. 23 to expose theannuloplasty device201.
• In one embodiment, a portion of the[0132]detaching mechanism106 belongs to theannular device201 and a portion of thedetaching mechanism106 belongs to thedelivery device203. Thus, the detachingmechanisms106 may contain portions that remain with theannuloplasty device201 that is delivered or deployed in theCS208.
• In one embodiment, the[0133]cord assembly105 includes a lumen (not shown). A guidewire can be disposed through this lumen thus eliminating the need for having aguidewire lumen111 in the outer sheath107 to guide theannuloplasty device201 of the medical device200A into theCS208.
• In one embodiment, both the[0134]distal anchoring member102 andproximal anchoring member103 are configured as self-expanding structures. Thedistal anchoring member102 can be any of the distal anchoring members previously described. Theproximal anchoring member103 can be any of the proximal anchoring members previously described. In one embodiment, the proximal anchoring members comprise anchors (not shown); these anchors are not oriented distally relative to the proximal anchoring members to prevent the anchors from penetrating into theinner sheath108 of thedelivery device203 and prevents the withdrawal of theinner sheath108. In another embodiment, the proximal anchoring members comprise anchors that may be oriented distally and another delivery device such as those shown in FIGS.26-28 (see below) can be used to deliver/deploy the annular device with these proximal anchoring members.
• Continuing with FIG. 23, the[0135]distal tube100 and theproximal tube101 form a telescoping assembly much like thetelescoping assembly220 previously described except only two tubes are used instead of three tubes as in thetelescoping assembly220. Theproximal tube101 and thedistal tube100 can slide inward and outward from each other. In one embodiment, theproximal tube101 enters the inner diameter of thedistal tube100 for a short distance, forming a telescoping section. The distal end of thedistal tube100 is further attached to one side of thedistal anchoring member102. The proximal end of theproximal tube101 is attached to one side of the proximal side of theproximal anchoring member103.
• Still referring to FIG. 23, in one embodiment, the proximal portion of the[0136]cord assembly105 is attached to the proximal end or any other portion of theproximal tube101. In another embodiment, the proximal portion of thecord assembly105 is attached to the proximal end of thedetaching mechanism106. The distal end of thecord assembly105 goes through the position-lockingdevice104. Thecord assembly105 extends some distance out of the position-lockingdevice104. The bulk of the cord assembly105 (not visible) runs through the inner diameters of thedistal tube100 and theproximal tube101. Thecord assembly105 is used by the operator (e.g., a physician) to adjust the length and/or tension of theannuloplasty device201 of the medical device200A.
• For example, pulling on the[0137]cord assembly105 moves thedistal tube100 and theproximal tube101, thereby telescoping the tubes, one relative to the other, thereby adjusting the length of the device. Thecord assembly105 may be used to apply tension upon thedistal anchoring member102 or theproximal anchoring member103. For example, when thecord assembly105 is also attached to an end of thedistal anchoring member102, pulling on thecord assembly105 adjusts the length of theannuloplasty device201 of the medical device200A when thecord assembly105 is relatively inelastic. Pulling on thecord assembly105 adjusts its length and (installed) tension, when thecord assembly105 is relatively elastic. With theCS208 being curved, the deployed/deliveredannuloplasty device201 tends to curve to the curvature of theCS208. When theannuloplasty device201 is placed under tension (as caused by pulling thecord assembly105, a force is applied to theannuloplasty device201 and hence, theCS208, reducing the curvature of theCS208 and pushing the posterior leaflet closer to the anterior leaflet as previously described.
• In one embodiment, an extension-limiting cord (not shown) is disposed within the inner diameters of each of the[0138]distal tube100 and theproximal tube101. One end of the extension-limiting cord is attached to thedistal tube100 and one end of the extension-limiting cord is attached to theproximal tube101. The length of the extension-limiting cord is fixed such that if thedistal tube101 and theproximal tube100 are moved away from each other, the extension-limiting cord dictates the maximum length or distance that thedistal tube100 and theproximal tube101 can move away from each other.
• After all the necessary adjustment, the[0139]cord assembly105 is locked in position by the position-lockingdevice104. In one embodiment, the position-lockingdevice104 is attached to the distal end of thedistal tube100.
• The position-locking[0140]device104 can be an interference locking ratchet-like mechanism well known in the art that can be used to lock thecord assembly105. The position-lockingdevice104 may include an opening created in an elastic diaphragm and thecord assembly105 may include beads. Thecord assembly105 may be pulled in one direction, for example, distally with respect to the position-lockingdevice104. One of the beads on thecord assembly105 would be trapped at the opening thereby locking thecord assembly105 into a position, which prevents thecord assembly105 from moving backward (e.g., proximally). Each of these configurations of the position-lockingdevice104 operates to allow thecord assembly105 to be pulled in one direction and locked in position. Correcting or adjusting thecord assembly105 in the event of over tightening is difficult in these configurations. For instance, a great deal of force must be applied to pull thecord assembly105 in the opposite direction. However, since the position-lockingdevice104 is on the distal end of theannuloplasty device201 as shown in FIG. 23 and is relatively accessible to the physician, a tool may be provided to facilitate the correction of an over-tightening situation. When thecord assembly105 has been properly adjusted for the patient's anatomy, the physician may clip off any excess at the distal end of thecord assembly105.
• In one embodiment, the position-locking[0141]device104 comprises of ahousing357, anarm358 and apivot359 as shown in FIGS. 24A. Thehousing357 is shown partially cut-away and thecord assembly105 is shown inserted into thehousing357. One side of thecord assembly105 rides against theinside surface360 of thehousing357. In one embodiment, thecord assembly105 may be guided and/or held (slidably proximal and distal) in this position by features of thehousing357 or features attached to thehousing357 such as slots or holes (not shown).
• Continuing with FIGS.[0142]24A, thearm358 is rotatably attached to the inner diameter of thehousing357 by thepivot359. Thepivot359 may be a separate component, such as a pin or shaft, or it may be incorporated into the features of thehousing357 and thearm358. For instance, thearm357 may be molded with cylindrical projections that engage holes in thehousing357 to perform the functions of thepivot359. Thelever portion361 of thearm358 is constructed such that thearea362 of thelever portion361 is elastically deformed when thecord assembly105 is inserted into thehousing357, as shown. This elastic deformation imparts a force on thearm358 such that it will rotate on thepivot359, causing the surface363 of thearm358 to contact thecord assembly105, as shown.
• The[0143]lever portion361 and thesurface364 of thehousing357 may be designed and/or constructed and/or coated in a manner such that the friction between them is low. This allows theportion361 to move relative to thesurface364 as thearm358 pivots. The surface363 is constructed such that its distance from thepivot359 increases distally. Thus, if thecord assembly105 is moved distally (relative to the position-locking device104), the engagement/friction of thecord assembly105 with the surface363 will rotate the surface363 clockwise causing the contacting surface of the surface363 to tend to move away or disengage from thecord assembly105. Thus thecord assembly105 may be pulled distally. Conversely, if thecord assembly105 is moved proximally (relative to the position-locking device104), the engagement of thecord assembly105 with the surface363 will rotate the surface363 counterclockwise causing the contacting surface of the surface363 to pinch thecord assembly105 between the surface363 and thehousing surface360. This pinching constrains thecord assembly105 from moving proximally.
• In one embodiment, the surface[0144]363 and/or the applicable surface of thecord assembly105 may be coated with or made of materials to increase the friction between them and/or be contoured to mechanically engage (like gear teeth of various configurations) and thus assure that pinching reliably occurs. In one embodiment, the position-lockingdevice104 is configured such that the surface363 engages thehousing surface360, if thecord assembly105 is not present. This keeps the position-lockingdevice104 in a state such that thecord assembly105 may be easily inserted into the position-lockingdevice104.
• In one embodiment, prior to insertion into the body, the physician may grasp the distal end of the outer sheath[0145]107 and pull on the distal end of thecord assembly105 to set the length and/or tension (depending upon the elasticity of the cord assembly105) of the annuloplasty device. There may be indicator markings/colors on the distal end of thecord assembly105 or the outer sheath107 may be see-through and contain a scale or a scale may be placed ontube101 to facilitate the proper and repeatable setting.
• In one embodiment, the length and/or tension of the[0146]annuloplasty device201 of the medical device200A is adjusted prior to being introduced into a patient. To adjust the annuloplasty device of the medical device200A prior to introducing it into the patient, an operator (e.g., a physician) needs to know the length and curve that the annuloplasty device of the medical device200A needs to be at in order to reshape the mitral valve annulus or the mitral valve. Methods such as TEE (Trans-Esophageal Echo) or TTE (Transthoracic Echo) imaging devices and methods can be used by the operator or the physician to diagnose mitral valve anomalies and to size theannuloplasty device201 of the medical device200A accordingly. Other methods that help the physician determine the anomalies of the mitral valve may also be used. The physician may use the image information to determine the desired length and/or shortening force of theannuloplasty device201 of the medical device200A. Theannuloplasty device201 of the medical device200A can then be adjusted outside of the patient and be deployed into the patient with the proper length or tension.
• Returning to FIG. 23, the distal end of the[0147]delivery de vice203 of the medical device200A is shown in a cutaway section. The outer sheath107 can be a catheter having at least one elongate lumen. The outer sheath107 includes a slitted/slotteddistal tip110 and theguidewire lumen111. One function of the outer sheath107 is to constrain thedistal anchoring member102 in a pre-delivery or pre-deployment state. The inner diameter of the outer sheath107 constrains the outer diameter of thedistal anchoring member102. The outer diameter of thedistal anchoring member102 should be constrained to the smallest outer diameter practical given the outer diameter of thedistal tube100. The outer sheath107 may also incorporate a radiopaque marker(s) (not shown) to provide fluoroscopic positioning information.
• The[0148]inner sheath108 is slidably disposed within the inner diameter of the outer sheath107. Theinner sheath108 is also elongate and contains at least one lumen. The distal end of the inner sheath butts up against the proximal end of thetube100. One function of theinner sheath108 is to constrain theproximal anchor103 in a pre-delivery or pre-deployment state. The inner diameter of theinner sheath108 constrains the outer diameter of theproximal anchoring member103. The outer diameter of theproximal anchoring member103 should be constrained to the smallest outer diameter practical. Theinner sheath108 may also contain a radiopaque marker(s) (not shown) to provide fluoroscopic positioning information.
• An[0149]inner shaft109 is slidably contained within the inner diameter of theinner sheath108. The distal end of theinner shaft109 contains features that allow it to be attached and detached from thedetaching mechanism106. Thedetaching mechanism106 comprises a distal and proximal portion. The distal portion is attached or incorporated into the proximal end of the telescoping assembly, theproximal tube101. The proximal portion is attached or incorporated into the distal end of theinner shaft109. Thedetaching mechanism16 is used to detach thedelivery device203 from theannuloplasty device201 after theannuloplasty device201 has been deployed into its final position in theCS208. For instance, thedetaching mechanism106 could contain screw threads, in which case the distal end of theinner shaft109 would contain the mating threads. Thedetaching mechanism106 could be a loop, in which case the distal end of theinner shaft109 could be hollow and containing an engaging loop. The loop can be a cord, wire, filament, or a hook, to name a few. There are many engagement/disengagement mechanisms that rely on rotary and/or longitudinal motion and/or the release of one end of a cord.
• In one embodiment, the[0150]distal anchoring member102 is deployed in theCS208. Thedistal anchoring member102 is deployed before theproximal anchoring member103 is deployed. To deploy thedistal anchoring member102, the outer sheath107 is withdrawn proximally relative to theinner sheath108. The outer sheath107 is also withdrawn proximally relative to theproximal anchoring member103. During deployment, thedistal anchoring member102 remains stationary. One reason for that is that thedistal anchoring member102 is attached to thedistal tube100, which is held stationary by being butted up against theinner sheath108. Thus, theinner sheath108 is held stationary while theouter sheath108 is pulled proximally, thereby exposing thedistal anchoring member102 and thedistal tube100 and theproximal tube101. The outer sheath107 can be withdrawn proximally over thedistal anchoring member102 and thetubes100 and161 while thedistal anchoring member102 and thetubes100 and101 remain in place in theCS208 because of the opening in the slitted/slotteddistal tip110 which opens enough to allow the outer sheath107 to be slid over thedistal anchoring member102 and thetubes100 and101.
• Once the[0151]distal anchoring member102 is deployed, theproximal anchoring member103 must be pulled proximally into position near or at the entrance to theCS208 for deployment. Pulling theproximal anchoring member103 may deform and/or reposition the anatomy of the heart as well as other anatomical structures along the path of theannuloplasty device201 of the medical device200A especially when theannuloplasty device201 has already been pre-sized to have a length that is sufficiently short to reduce or reform the mitral valve annulus. The desired position of theproximal anchoring member103 is attained prior to deployment using a balloon on aguide catheter shaft112. Thedelivery device203 is disposed within the inner diameter of theguide catheter shaft112. Theguide catheter shaft112 couples to a dilatable/inflatable balloon113. Theguide catheter shaft112 may have any of the constructions common to guides and/or introducer sheaths/catheters. Theguide catheter shaft112 includes alumen114 to inflate or dilate theballoon113. Thelumen114 is in communication with the proximal end of the guide catheter in a manner that facilitates the inflation and deflation of theballoon113. Any of the common angioplasty balloon materials may be used. In one embodiment, theballoon113 is made of nylon (e.g., Pebax blend or nylon/Pebax blend materials that are commonly use in guide/introducer construction) balloon materials.
• Once the[0152]distal anchoring member102 is deployed, theproximal anchoring member103 is positioned by first inflating theballoon113. Theinner shaft109 is pulled proximally with one hand, while grasping the proximal end of theguide catheter shaft112 with the other hand and pushing in the opposite direction. This forces theguide catheter shaft112 to move distally such that the distal end of theinflated balloon113 pushes against the right atrium wall. From that point on, the bulk of the force and longitudinal displacement applied between theinner shaft109 and theguide catheter shaft112 is applied mainly to the distance between thedistal anchoring member102 and theballoon113 contact areas around the entrance to theCS208. Once the correct position for theproximal anchoring member103 is attained, theinner shaft109 is withdrawn to deploy theproximal anchoring member103.
• In one embodiment, the[0153]annuloplasty device201 is delivered into theCS208 using the following procedure. First, the operator (e.g., a physician) gains access to a vein (e.g., femoral, jugular, subclavian, etc...) in a patient's body using a cut-down or an introducer sheath procedure. The vein is used to introduce the medial device200A into the right atrium and then into theCS208. In the introducer sheath procedure, the physician introduces the introducer sheath into the vein through the patient's skin percutaneously. A needle or a similar puncture device provides entry into the vein. The proximal end of the needle remains outside of the introducer sheath and is withdrawn. A distal end of thecatheter guide shaft112 with a flexible guidewire (not shown) in its inner diameter is inserted into the proximal end of the introducer sheath and advanced therethrough until the distal end of the guidewire or theguide catheter shaft112 reaches the vicinity of theCS208.
• Second, the guidewire and the[0154]catheter shaft112 are manipulated to gain access to the entrance to theCS208. Once theguide catheter shaft112 is inserted into the CS208 a short distance, the guidewire may be withdrawn proximally from theguide catheter shaft112 and replaced with another guidewire (not shown) that is suitably sized for thelumen111 of the outer sheath107. This other guidewire is inserted into the proximal end of theguide catheter shaft112 until its distal end is distal to the desired position of thedistal anchoring member102.
• Third, the length of the[0155]annuloplasty device201 of the medical device200A is adjusted to a desirable length outside of the patient using thecord assembly105. Excess portion of thecord assembly105 may be cut off. The physician may also flush the delivery system, theguide catheter112 and theannuloplasty device201 of the medical device200A.
• Fourth, the[0156]annuloplasty device201 disposed within thedelivery device203 is inserted into theguide catheter112 and over the guidewire. The guidewire is inserted within theguidewire lumen111 so that theannuloplasty device201 of the medical device200A can be inserted over it and into the inner diameter of theguide catheter shaft112. Theannuloplasty device201 of the medical device200A is advanced until the distal portion of theannuloplasty device201 reaches an area in theCS208 where thedistal anchoring member102 is to be deployed, for example, in the vicinity of the left trigone.
• Fifth, the physician withdraws this other guidewire and deploys the[0157]distal anchoring member102. The physician withdraws the guidewire proximally and removes it from the proximal end of theguide catheter shaft112. The physician withdraws the outer sheath107 to deploy thedistal anchoring member102. The outer sheath107 is withdrawn proximal to theproximal anchoring member103.
• Sixth, the physician positions and deploys the[0158]proximal anchoring member103. Theguide catheter shaft112 is withdrawn until the distal tip of theguide catheter shaft112 is not in theCS208. Theballoon113 is inflated, for example, by air, water, saline, contrast, gas, etc... Theguide catheter shaft112 is advanced distally until theguide catheter112 contacts the right atrium wall. In one embodiment, the physician grasps the proximal end of theguide catheter shaft112 in one hand and the proximal and of theinner shaft109 in the other hand and moves them apart. This action moves theproximal anchoring member103 to the desired location, for example, at the entrance of theCS208. Theinner sheath108 is then withdrawn to deploy theproximal anchoring member103.
• Seventh, after deploying the[0159]distal anchoring member102 and theproximal anchoring member103, theballoon113 is deflated. The physician manipulates thedetaching mechanism106 to release theannuloplasty device201 from theinner shaft109. The physician may then withdraw and remove thedelivery device203 proximally form theguide catheter shaft112. The physician may then withdraw and remove the introducer sheath from the patient. The length and resistance to curvature (flexural modulus) of the telescoping assembly then acts to reshape theCS208 thereby reshaping themitral valve annulus209. In one embodiment, reshaping the mitral valves annulus209 includes moving the posterior leaflet of the mitral valve toward the anterior leaflet of the mitral valve and thus reduces or eliminates regurgitation.
• The annuloplasty device need not have its length or tension pre-adjusted prior to introducing it into the patient. In one embodiment, the position-locking[0160]device104 is attached to the proximal end of theproximal tube101 or to theproximal anchoring member103 to allow for adjustment of the length or tension of the annuloplasty device after its deployment into theCS208. Such an embodiment is amedical device200B illustrated in FIG. 25 below. The position-lockingdevice104 for the annuloplasty device of themedical device200B is oriented in the opposite direction (see FIG. 24B) from the one for theannuloplasty device201 of the medical device200A described above.
• FIG. 25 illustrates an exemplary embodiment of a[0161]medical device200B that can be used to treat mitral valve regurgitation. Although the discussion below focuses on treating mitral valve regurgitation, themedical device200B can be used to treat other conditions that require re-shaping or reducing a blood vessel. Themedical device200B is similar to the medical device200A described above except that the annuloplasty device of themedical device200B has the position-lockingdevice104 attached to the proximal end of the telescoping assembly and that the annuloplasty device of themedical device200B allows for adjustment to the length and/or tension of the annuloplasty device of themedical device200B after the annuloplasty device of themedical device200B has been introduced into the patient.
• As illustrated in FIG. 25, the[0162]medical device200B comprises anannuloplasty device205 and adelivery device207. Theannuloplasty device205 comprises adistal anchoring member42, atelescoping assembly74, a proximal anchoringmember35, acord assembly105, and a position-lockingdevice104 which is not visible in FIG. 25 but which is attached to the proximal end of the proximal anchoringmember35 or theproximal tube80.
• The[0163]telescoping assembly74 can also be thetelescoping assembly220 previously described, but for simplicity only two tubes are included in FIG. 25. Thetelescoping assembly74 of theannuloplasty device205 may comprise adistal tube76 and aproximal tube80. Thedistal tube76 can slide into theproximal tube80, similar to that previously described for thetelescoping assembly220. The inner diameter of thedistal tube76 is shown with two steps in its inner diameter that will interfere with theouter diameter step79 on the distal end of theproximal tube80, such that theouter diameter step79 is captured. Theproximal tube80 thus only telescopes between the two inner diameter steps of thedistal tube76. Theouter diameter step79 is shown up against the inner diameter step of thedistal tube76, and therefore, the full device is shown in FIG. 25 at its shortest length, which should be chosen to be shorter than the deployed device length and to preferably also be the target minimum modified annulus length. In another embodiment, thetelescoping assembly74 may be mounted in theannuloplasty device205 of themedical device200B such that it is at or near its longest length to provide the greatest flexibility to thedistal section70 and thus provide the easiest delivery to theCS208.
• The[0164]delivery device207 delivers and deploys theannuloplasty device205 to the treatment site (e.g., the CS208) to reshape themitral valve annulus209. Thedelivery device207 of themedical device200B comprises anouter sheath67 and aninner sheath73. In one embodiment, the outer sheath67 (shown as a cutaway section) is slidably mounted over the outer diameter of theinner sheath73. The distal end of theouter sheath67 may be withdrawn proximally to a position that is proximal to the distal end ofinner sheath73. Similar to theannuloplasty device201 of the medical device200A, the proximal withdrawal of theouter sheath67 allows theannuloplasty device205 of themedical device200B to be deployed. Thedelivery device207 further includes adistal tip77, adistal section70 and aproximal section71. Thedistal tip77 is part of theouter sheath67 and is attached to thedistal section70 to provide an atraumatic tip to theouter sheath67. The atraumaticdistal tip77 may include one or more cut slots/slits78 (or cuts or partial cuts), such that when theouter sheath67 is withdrawn over the inner sheath63, thetip77 opens and passes over the distal end of theinner sheath73. In another embodiment, the atraumaticdistal tip77 may be incorporated into the distal end of the telescoping assembly of theannuloplasty device205, or if present, the position-locking device.
• In one embodiment, the[0165]outer sheath67 has variable wall thickness/flexural modulus. For example, thedistal portion70 of theouter sheath76 has aside69 and aside68 wherein theside69 has a higher flexural modulus (higher stiffness) than theside68. The high flexural modulus on theside69 allows for orientation control of thedelivery device207 and thereby, theannuloplasty device205 as previously described. Controlling the orientation of thedelivery device207 allows the anchoring members and thetelescoping assembly74 to be deployed in a proper orientation (e.g., these elements are in contact with the wall of theCS208 which faces the mitral valve annulus209). In one embodiment, some portions of thedistal section70 include in its construction stiffer materials in the form of wires, rods, partial tube sections and other shapes to provide the desired change in flexural modulus.
• In one embodiment, the[0166]outer sheath67 includes aguidewire lumen75 at thedistal portion70. Theguidewire lumen75 may be located on theside69 of thedistal portion70. Theguidewire lumen75 accommodates a guidewire (not shown) to facilitate the delivery of theannuloplasty device205 of themedical device200B. Also, the incorporation of theguidewire lumen75 into theouter sheath67 requires the addition of material that may provide the differential flexural modulus in thedistal section70 that provide the orientation control previously described. In one embodiment, theouter sheath67 includes at least oneradiopaque marker72 that aids in the positioning of the deployment of theannuloplasty device205 of themedical device200B.
• In one embodiment, the[0167]distal tube76 is attached to thedistal anchoring member42 and theproximal tube80 is attached to the proximal anchoringmember35. Thedistal anchoring member42 and the proximal anchoringmember35 can be any of the anchoring members previously described.
• In one embodiment, the[0168]telescoping assembly74 is disposed on the inner diameter of theouter sheath67 on the side that curves to the curve of theCS208 such that thedistal anchoring member42, thetelescoping assembly74, and the proximal anchoringmember35 are in contact with the wall of theCS208 that faces the mitral valve annulus. Delivering theannuloplasty device205 in this manner ensures that subsequent tension on thecord105 will not introduce undesirable forces on thedistal anchoring member42 and the proximal anchoringmember35.
• FIG. 24B illustrates a position-locking[0169]device104 that can be used for theannuloplasty device205 of themedical device200B. This position-lockingdevice104 is the same as previously described in FIG. 24A except that the position of thearm358 is opposite from the one shown in FIG. 24A.
• In one embodiment, the position-locking[0170]device104 enables adjustment of thecord assembly105. The position-lockingdevice104 may be manipulated in several simple ways to allow thecord assembly105 to be released in the event of over-tightening. In one embodiment, a pin/wire is inserted through theinner sheath73 and pushed out to engage thesurface366 ofarea362, and then thearm358 will pivot away from thecord assembly105 releasing it. In another embodiment, a similar pin or catheter end portion may engage and push on thesurface365 of thelever361 to cause thearm358 to pivot away from thecord assembly105 to releasing thecord assembly105. An example of such a pin/wire is apush wire81 shown in FIG. 25. The amount of force/pressure required for release can be reduced dramatically by also pulling thecord assembly105 proximally slightly. Once released the amount of force/pressure on thesurface365 or366 required to keep thecord assembly105 released will be near this lower level. Thus either of the previously described release methods may be combined with a small proximal pull, then release of thecord assembly105 relative to the engaging catheter to release thecord assembly105 from the position-lockingdevice104 using a minimal force/pressure.
• In one embodiment, the position-locking[0171]device104 is attached to or interferes with the proximal anchoringmember35 in a convenient manner such that thecord assembly105 is routed through the inner diameter ofproximal tube80. In another embodiment, the position-lockingdevice104 is attached to or interferes with theproximal tube80 in a convenient manner such that thecord assembly105 is routed through its inner diameter.
• In one embodiment, when the[0172]outer sheath67 is withdrawn, thedistal anchoring member42, thetelescoping assembly74, and the proximal anchoringmember34 will be exposed and thus deployed. The distal end of theinner sheath73 engages the position-locking device104 (which is attached to the proximal tube80), as previously described. In one embodiment, theinner sheath73 comprises at least two lumens (not shown), which accommodate thecord puller83 and the lockrelease push wire81. The proximal end of thecord assembly105 is formed as aloop82 andpuller cord83 goes through that loop. When the two ends ofpuller cord83 are pulled, then thecord assembly105 is tightened. When only one end of thepuller cord83 is pulled, its unpulled end is pulled through the inner diameter of one of the lumens of theinner sheath73 and through theloop82 disengaging the full annuloplasty device frominner sheath73. In one embodiment, thepush wire81 acts as previously described to allow the unlocking of thecord assembly105 from the position-lockingdevice104 for adjustment in the event of over tightening.
• In one embodiment, the[0173]cord assembly105 and thesurface360 of thehousing357 are designed and/or constructed and/or coated in a manner such that the friction between them is not an appreciable portion of the desirable tension for thecord assembly105 during tightening. This provides the physician with tactile feedback or the tightening monitoring of the annuloplasty device of themedical device200B. The tactile feedback for the tightening monitoring is useful when the tightening of thecord assembly105 occurs while the annuloplasty device of themedical device200B is deployed/delivered inside the body.
• In one embodiment, the[0174]inner sheath73 comprises a metallic braid, coil(s) and/or slotted tube in its wall to aid theinner sheath73 it in resisting compression during device deployment and still keep the necessary flexibility for deliverability and the desirable thin walls to make the delivery system as small in outer diameter as practical.
• In one embodiment, the delivery device portion of the[0175]medical device200A or200B is configured to have a preferred orientation that is similar to the curve of the blood vessel (or the CS208). For example, as mentioned above, the outer sheath107 of thedelivery device203 of the medical device200A or theouter sheath67 of thedelivery device207 of themedical device200B has sections with variable flexural modulus. The suitable delivery device may have sides or sections that have a higher flexural modulus such that one side of the delivery device is stiffer than the opposite side. Such a delivery device helps aligning the distal anchoring and the proximal anchoring members with the delivery device's preferred orientation. One advantage for the orientation is that the anchors that may be present in the distal anchoring or the proximal anchoring members are oriented to the inside of the curve. Delivery devices for themedical devices200A or200B with differential stiffness or variable flexural modulus can be made using well known methods in the art. In an embodiment where the outer sheath of the delivery device includes a hollow shaft, the wall of the hollow shaft may have its wall made thicker on one side than the other. In an embodiment where the delivery device includes an extruded tube that is made with its wall on one side thicker than the other. In one embodiment, the delivery device includes a shaft that is made out of two different grades of similar (miscible) plastics, where one grade is stiffer than the other grade, either by co-extrusion or other melt processes, such as melting cut lengths of the two materials (in a properly formed condition) within a shrink tubing over a mandrel. In one embodiment, the delivery device may have a stiffer material inserted/melted into one side of the delivery device.
• Additionally, orienting the distal anchoring and the proximal anchoring members in a particular orientation (e.g., toward the inside curve of the CS[0176]208) aids the anchors that may be included in the distal anchoring and the proximal anchoring members to project toward and/or penetrate toward the inside of the curve of the blood vessel as discussed above. Also, the anchors may be oriented in any other direction that will prevent the anchors from damaging other vessels or other thinner sections of the heart.
• The[0177]annuloplasty device205 of themedical device200B can be deployed using the following exemplary procedure. Using conventional methods, theCS208 is accessed by a guide catheter (or guide catheter with an occluding balloon and/or deflection capabilities) and a guidewire. Using angiography (with the guide catheter and contrast injections through the guide catheter) and/or previously obtained or concurrent echo data, the desired position of thedistal anchoring member42 is determined. Fluoroscopic/angiographic observation methods can be used to aid the physician in deploying theannuloplasty device205 of themedical device200B. These methods are well known in the art.
• The[0178]annuloplasty device205 disposed within thedelivery device207 is advanced over the guidewire using thelumen75 until the distal end of thedistal anchoring member42 is in the desired position, for example, an area in theCS208 that is proximate the left trigone. The guidewire is withdrawn/removed from theCS208. To deploy thedistal anchoring member42, theinner sheath73 is used to hold thedistal anchoring member42 in position (via the telescoping assembly74) while theouter sheath67 is withdrawn until themarker72 and thedistal tip77 pass the proximal end of thedistal anchoring member42. Once thedistal anchoring member42 is deployed, it engages the inner wall of theCS208 and is fixed in position. Thepush wire81 is then advance to release thecord assembly105 from the position-lockingdevice104, as described above and the proximal end of thedelivery device207 is withdrawn proximally, lengthening thetelescoping assembly74, until the proximal anchoring member is at the desired position in theCS208. Theproximal anchoring member35 is then deployed at the entrance to the CS as theouter sheath67 is further withdrawn. Theinner sheath73 is used to hold the proximal anchoringmember35 in position while theouter sheath67 is withdrawn until themarker72 and thedistal tip77 pass the proximal end of the proximal anchoringmember35. The length and tension of theannuloplasty device205 of themedical device200B is then adjusted by pulling on both ends of thepuller cord83 relative to theinner sheath73 to place tension/longitudinal motion on thecord assembly105. When thecord assembly105 has been given the proper amount of tension, shortening and/or the valve regurgitation has been eliminated or reduced to the target amount, one end of thepuller cord83 is released and withdrawal of thepuller cord83 is continued until it releases thecord assembly105. Thedelivery device207 of themedical device200B is then removed in a conventional manner.
• FIGS.[0179]26-28 illustrate an exemplarymedical device200C. The configuration of themedical device200C is similar to themedical device200B and includes most of the features of themedical device200B described above. Themedical device200C includes anannuloplasty device209 and adelivery device211 which are similar to theannuloplasty device205 and thedelivery device207 of themedical device200B. FIG. 26 illustrates the distal end of theannuloplasty device209 of themedical device200C as it would be inserted into a guide and into theCS208 wherein theannuloplasty device209 is not yet deployed.
• Similar to the[0180]annuloplasty device205 of themedical device200B, theannuloplasty device209 of themedical device200C comprises adistal anchoring member42, a proximal anchoringmember35, and atelescoping assembly88, which includes acenter tube87, a distal tube90, and aproximal tube91. The distal tube90 and theproximal tube91 can telescope into thecenter tube87. Additionally, theannuloplasty device209 of themedical device200C includes aspring89 which functions to bias the distal tube90 and theproximal tube91 to a minimal distance away from each other. For example, thespring89 provides a small biasing force to cause the other tubes90,91 (shown in cutaway sectional views) to remain as far apart as possible in the absence of other forces. Without this biasing force the distal end ofinner sheath73 would not remain engaged with the position-locking device (not shown) on the proximal anchoringmember35 during deployment of the proximal anchoringmember35 on the right atrium wall.
• All other features of the[0181]annuloplasty device209 of themedical device200C are similar to theannuloplasty device207 of themedical device200B previously described.
• The[0182]delivery device211 of themedical device200C is similar to thedelivery device207 of themedical device200B. Thedelivery device211 comprises aninner sheath73, anouter sheath67, adistal tip77, and at least oneradiopaque marker72, Additionally, thedelivery device211 includes aprotective sheath84 as illustrated in FIGS.26-28. Thedistal tip77 also includes aslit78.
• The[0183]outer sheath67 of thedelivery device211 is of the same design as previously described for thedelivery device207 of themedical device200B. Theouter sheath67 also includes aguidewire lumen75 that is away from the viewer and, therefore, is not seen in this sectional view. Theouter sheath67 includes aradiopaque marker72 and adistal tip77, shown with theslot78 to allow it to be withdrawn similar to thedelivery device207 of themedical device200B. Thesheath67 also performs the orientation control which functions similarly to previously described. Theinner sheath73 of thedelivery device209 is also of the same design as previously described for thedelivery device207 of themedical device200B.
• As will be apparent with the discussion below, in one embodiment, the[0184]protective sheath84 functions to constrain and shield the anchors49 (e.g., barbs) that are present on the proximal anchoringmember35 from interfering with the withdrawal of theouter sheath67 during deployment. Without this protection, theanchors49, being directed distally, would engage theouter sheath67 and prevent its withdrawal. Theprotective sheath84 is cut longitudinally by aslit85 and folded over into the shape of a tube. Theprotective sheath84 presses up against the inner diameter of theouter sheath67 in its slit portion. The distal end of theprotective sheath84 engages the proximal end of thedistal anchoring member42 and prevents thedistal anchoring member42 from moving proximally as theouter sheath67 is withdrawn during deployment. The proximal portions of protective sheath84 (not shown) may be a simple tube (containing no slit) that occupies the space between the inner diameter of theouter sheath67 and the outer diameter of theinner sheath73. As theouter sheath67 is withdrawn just proximal to thedistal anchoring member42, thedistal anchoring member42 is deployed in theCS208 or other blood vessel. Once theproximal anchoring member35 is in position, theouter sheath67 is withdrawn proximal to the proximal anchoringmember35 and theprotective sheath84 opens up as shown in FIG. 27. Theprotective sheath84 may then be withdrawn proximal into theouter sheath67 to not interfere with the rest of the deployment procedure.
• In one embodiment, the slit portion of the[0185]protective sheath84 includeselastic members86 to aid the slit portion of theprotective sheath84 to open for the deployment of the proximal anchoringmember35. Often, even though the slit portion of theprotective sheath84 was molded or shaped to be relatively flat when unconstrained, after being shaped back into an arc or a tube form for a period of time, theprotective sheath84 may take back its original shape, arc or tube, due to the creep properties of many polymers. Thus, when theouter sheath67 is withdrawn, theprotective sheath84 may not open up to deploy the proximal anchoringmember35 in the desired manner. Theelastic members86 are made of material(s) that will resume its shape in a way that helps thatprotective sheath84 in opening up as theouter sheath67 is withdrawn.
• In one embodiment, when the[0186]outer sheath67 is withdrawn, the opening of theprotective sheath84 is not necessarily all the way to a flat cross-section, some residual curvature may be desirable for its subsequent withdrawal into theouter sheath67. Withdrawal of theprotective sheath84 into theouter sheath67 causes theprotective sheath84 to refold into a tube-like cross-section.
• In one embodiment, the opening up of[0187]protective sheath84 allows theproximal anchor35 to unfold in a manner that directs itsanchors49 away from theprotective sheath84. As can be understood, if theprotective sheath84 was not folded over theproximal anchoring device35, then theanchors49 would engage the inner diameter of theouter sheath67 when it is withdrawn. In one embodiment, theslit85 is oriented such thatprotective sheath84 unfolds to a position behind theanchors49. Theprotective sheath84 can be subsequently withdrawn, as shown in FIG. 28. The opening up ofprotective sheath84 behind theanchors49 and toward the outside of the curve of theCS208 may further aid in the orientation control of thedelivery device211 and thereby theannuloplasty device209 of themedical device200C.
• As can be readily appreciated by one skilled in the art, the[0188]annuloplasty device209 of themedical device200C can be deployed using a procedure very similar to that previously described for delivering theannuloplasty device205 of themedical device200B but modified with the previously described steps to deal with theprotection sheath84 and to account for thetelescoping assembly88 being biased in its most extended condition.
• FIG. 29 illustrates an exemplary embodiment of an[0189]annuloplasty device601 that comprises adistal anchoring member604, aproximal anchoring member606, aligature600, and anexpandable structure602. The term ligature is used to include at least a strap, string, cord, wire, bond, thread, suture, backbone, or other connector. Theligature600 is deployed within theCS208 along one side of theCS208 wall. Theexpandable structure602 is deployed within theCS208. Theexpandable structure602 may be a stent-like structure that is deployed against the inner diameter of theCS208. Thedistal anchoring member604 anchors into a cardiac tissue that is proximate theCS208, for example, the left trigone608. Theproximal anchoring member606 anchors into a cardiac tissue that is proximate theCS208 and near theentrance216 of theCS208, for example, theright trigone610.
• In one embodiment, once the[0190]annuloplasty device601 is fully deployed, theannuloplasty device601 reshapes theannulus209 of themitral valve208.
• FIG. 30 illustrates three-dimensional views of the[0191]annuloplasty device601. In one embodiment, theligature600 is made of a material that could be manufactured in a specific shape, such as a c-shape. The material could be flexible to allow the ligature to be straightened and held in a straightened conformation by the delivery system that is employed to deliver theannuloplasty device601 into theCS208. In another embodiment, theligature600 is made of a polymeric material, an elastic material, a shape memory metal or a shrinkable material. In one embodiment, theligature600 is made of a material that could be shrunk after it is deployed by an energy source such as IR, RF, an Inductive, UV, or Ultrasound. In yet another embodiment, theligature600 is configured to be mechanically shortened such as by folding, bending, or flexing of the structural members of theligature600, or by flexing of joins or hinges designed into theligature600.
• Still referring to FIG. 30, the[0192]expandable structure602 is made of a material that would allow it to be expandable (e.g., by an inflatable balloon) or self-expandable. Theexpandable structure602 may also only need to be made of a material that provides only a minimal amount of redial strength. Theexpandable structure602 may be deployed against only the inner diameter of theCS208 but need not hold open theCS208 such as in the case of a stent used in an angioplasty procedure where the stent is used to open a clogged or closed artery. Theexpandable structure602 needs not be rigid, but may be, depending on the application of theannuloplasty device601. Theexpandable structure602 could be made of polymeric materials, flexible materials, shape memory materials or metals. Theexpandable structure602 could be made from materials and designs that are used to make conventional stents. Theexpandable structure602 may be divided into a plurality of expandable rings602A to enhance shaping of theCS208. Theexpandable structure602 may include one expandable ring602A or a plurality of the expandable rings602A.
• In one embodiment, the[0193]ligature600 has a predetermined curvature that is used to reshape themitral valve annulus209. Theligature600 is made of a shaped-memory material that will hold the curvature once theannuloplasty device601 is deployed. In this embodiment, theexpandable structure602 is capable of maintaining a curvature, for example the predetermined curvature. When theexpandable structure602 is expanded, it adds force or support to maintain or to reinforce the predetermined curvature of thecurved ligature600.
• The[0194]distal anchoring member604 and theproximal anchoring member606 may have configuration of coils, helixes, anchors, hooks, barbs, screws, flanges, and other features that allow the anchoring members to penetrate or attach to a myocardial tissue (or cardiac tissue). It is to be appreciated that each of thedistal anchoring members604 and606 may include a plurality of anchors. For instance, thedistal anchoring member604 may include three anchors604a,604b, and604cand theproximal anchoring member606 may include three anchors606a,606b, and606cas shown in FIG. 30.
• The[0195]ligature600, theexpandable structure602, thedistal anchoring member604, and theproximal anchoring member606 may be made from the same material. For example, these structures can be cut out of a tube or a structure and formed into the appropriate configurations. Alternatively, these structures may be laser welded together or otherwise adhered together by using materials such as adhesive or methods well known in the art. The methods of making these structures will be evident to those skilled in the art.
• There are several ways of deploying the[0196]expandable structure602 as illustrated in FIGS.31-33.
• In one embodiment, as illustrated in FIG. 31, a[0197]balloon11 is used to expand theexpandable structure602. Theballoon11 includes adistal end5, aproximal end15, and aguidewire lumen20 extending from thedistal end5 to theproximal end15. Aguidewire13 is disposed in the inner diameter of theguidewire lumen15. Theguidewire13 is a straight guidewire. Theballoon11 is configured to inflate into a curved balloon upon proper inflation. Theballoon11 has variable thickness along the wall of theballoon11 thus, upon inflation, theballoon11 can take on the curved shape. In this embodiment, theexpandable structure602 is disposed on the outside of theballoon11 and upon inflation, thecurved balloon11 helps expanding theexpandable structure602 into the desired curve and shape.
• In one embodiment, as illustrated in FIG. 32, the[0198]balloon11 is used to expand theexpandable structure602. Theballoon11 includes adistal end5, aproximal end15, and aguidewire lumen20 extending from thedistal end5 to theproximal end15. Aguidewire13 is disposed in the inner diameter of theguidewire lumen15. Theguidewire13 is a curved guidewire that is shaped to a desired curve that theexpandable structure602 needs to have. As theguidewire13 is disposed within theballoon11, theballoon11 curves as shown in the figure. Theballoon11 is configured to inflate into a curved balloon conforming to the curve of theguidewire13 upon proper inflation. Theballoon11 has variable thickness along the wall of theballoon11 to allow theballoon11 to take the curve of theguidewire13. In this embodiment, theexpandable structure602 is also disposed on the outside of theballoon11 and upon inflation, thecurved balloon11 helps expanding theexpandable structure602 into the desired curve and shape.
• In one embodiment, as illustrated in FIG. 33, a[0199]balloon30 is used to expand theexpandable structure602. Theballoon30 includes adistal end5, aproximal end15, and aguidewire lumen20 extending from thedistal end5 to theproximal end15. Theballoon30 is formed to have a curve shape that theexpandable structure602 needs to have. Aguidewire13 is disposed in the inner diameter of theguidewire lumen15. Theguidewire13 is a straight guidewire that straightens out thecurved balloon30 for easy delivery into theCS208. As theguidewire13 is disposed within theballoon30, theballoon30 straightens out as shown in the figure. After theballoon30 is delivered to the proper position for deploying theexpandable structure602, theguidewire13 is removed and the balloon returns to its original curved shape. Upon a proper inflation, theballoon30 inflates to expand theexpandable structure602. Theballoon30 has variable thickness along the wall of theballoon30 to allow theballoon30 to have the curved shape. Theballoon30 may also be made of shape-memory material or may include a tension strap that will help returning theballoon30 to the curved shape after theguidewire13 is withdrawn. In this embodiment, theexpandable structure602 is also disposed on the outside of theballoon30 and upon inflation, thecurved balloon30 helps expanding theexpandable structure602 into the desired curve and shape.
• FIGS.[0200]34-36 illustrate exemplary configuration of theexpandable structure602. Theexpandable structure602 comprises of a series ofexpandable rings612 having wave-like shape or sinusoidal shape in their unexpanded state. The expandable rings612 are held together by atension mechanism620. Thetension mechanism620 is made of a shaped-memory material that allows thetension mechanism620 to have a predetermined curvature. The predetermined curvature is configured to force theexpandable structure602 to conform to the curvature. In one embodiment, the predetermined curvature has the curvature of theCS208. In one embodiment, thetension mechanism620 is a filament or a backbone that is inserted through anaperture622 created in each of the expandable rings612. Each of the expandable rings612 includes aportion614 that includes a flat surface in one embodiment. A distance G_sseparates oneportion614 of onering612 from anotherportion614 of anotherring612. An angle θ_sseparates oneportion614 of onering612 from anotherportion614 of anotherring612.
• In one embodiment, tension is applied to the[0201]tension mechanism620, which causes theexpandable structure602 to bend in a curved fashion. In one embodiment, theexpandable structure602 is curved to a shape and size and that is desirable for reforming, reshaping, or reducing theannulus209 of themitral valve210. As shown in FIGS.37A-37C and FIGS.38-39, as tension is applied to thetension mechanism620, thetension mechanism620 pulls therings612 closer to each other on the sides of therings612 that include thetension mechanism620. Theexpandable structure602 is brought to the curved shape as thetension mechanism620 works to pull the expandable rings612 closer to each other. Because tension is only applied on one side of each of theexpandable rings612 by thetension mechanism620, theexpandable structure602 curves toward that side. As shown in FIG. 37A, when theexpandable structure602 is in a non-curved shape, the distance G_sbetween eachexpandable ring612 at theportion614 is larger than the distance G_c1between eachexpandable ring612 in a curved shape (G_c1<G_s) as shown in FIG. 37B.
• In one embodiment, as shown in FIGS.[0202]37A-37C, when theexpandable structure602 is in a non-curved shape, the angle θ_sbetween eachexpandable ring612 at theportion614 is larger than the angle θ_c1between eachexpandable ring612 in a curved shape (θ_c1<θ_s). And, in another embodiment, as shown in FIG. 37C, as thetension mechanism620 applies enough tension, theexpandable structure602 is in its most curved state wherein the distance and angle between each expandable rings612 atportions614 is near zero “0.” In this configuration, everyexpandable ring612 is positioned adjacent to the next ring with no distance between them.
• FIGS.[0203]38-39 illustrate other perspective views of theexpandable structure602 in its curved position. In one embodiment, the expandable rings612 are not yet fully expanded at this point. These figures also show that theexpandable structure602 includes sealingmembers624 located at the end of thetension mechanism620 to keep theexpandable rings612 from being detached from each other.
• FIG. 40 illustrates the[0204]expandable rings612 in their fully expanded state. In one embodiment, therings612 are fully expanded to have the shape of circular rings. When therings612 are fully expanded, each of therings612 has a diameter D₂₀that is greater than the diameter D₁₀of eachring612 when they are not fully expanded as shown in FIG. 39. In other embodiments, therings612 can be fully expanded to have shapes such as oval, oblong, or rings with wave-like shapes.
• In one embodiment, to provide the[0205]expandable structure602 with a curve shape, a curved-shape backbone630 shown in FIG. 41 is used. In one embodiment, the curved-shape backbone630 is a shaped-memory structure that has a natural curve shape that conforms to the curve of theCS208. As shown in FIG. 42, thebackbone630 is first coupled to one side of theexpandable structure602. Coupling thebackbone630 to theexpandable structure602 will cause theexpandable structure602 to take on the curved shape of thebackbone630. In this embodiment, thebackbone630 may replace thetension mechanism620 of the embodiments shown in FIGS.34-39. In order to deploy theexpandable structure602 into the CS808, theexpandable structure602 is temporarily straightened so that theexpandable structure602 can fit into a conventional delivery device (e.g., a balloon on a catheter). As shown in FIG. 42, astraightening wire626 is disposed within the inner diameter of theexpandable structure602. Each of therings612 may have a groove, a slot, or an aperture on one side where thestraightening wire626 can be disposed therethrough. Theexpandable structure602 is thus temporarily straightened. Theexpandable structure602 of this embodiment can be deployed and expanded with a balloon. Exemplary embodiments of the balloon delivery system that can be used include the embodiments shown in FIGS. 31 and 33.
• In one embodiment, as shown in FIG. 43, a curved expandable structure[0206]602 (e.g., as curved by thebackbone630 or by the tension mechanism620) that is temporarily straightened with astraightening wire626 is disposed on the outer diameter of aballoon11. Theballoon11 is “passive” and will take the curve shape of the curvedexpandable structure602 when thestraightening wire626 is removed after the curvedexpandable structure602 is delivered to the inner diameter of theCS208.
• FIG. 44 illustrate the curved[0207]expandable structure602 after it is delivered to the inner diameter of theCS208 and thestraightening wire626 is removed. The curvedexpandable structure602 is shown to return to the curve shape, and in this figure, that is conforming to the curve shape of thecurved shape backbone630. FIG. 45 illustrates an example of the curvedexpandable structure602 in its fully expanded state as theballoon11 is inflated by conventional methods. The balloon is then deflated, leaving the curved expandable supporting structure in place to reshape theCS208.
• In one embodiment, to provide the[0208]expandable structure602 with a curve shape, various links of various linear lengths are used to hold the expandable rings612 together as shown in FIGS.46-47. Using links of different linear lengths would expand theexpandable structure602 into a curved structure such that one side can curve in more than the other.
• In one embodiment, the various links with different linear lengths include a plurality of coiled/[0209]helical links632 and a plurality of coiled/helical links634. The coiled/helical links632 and634 are similar except that one may have more coils, turns, or period per unit length than the other. In one embodiment, the coiled/helical links632 is a coiled structure that has more turns, coils, and periods per unit length than that of the coiled/helical links634. For example, the coiled/helical links632 has four turns while the coiled/helical links634 has only 1 turn. The coiled/helical links634 has fewer curves and no turn. The coiled/helical links632 has a longer linear length than the coiled/helical links634 when the coiled/helical links632 is stretched.
• The plurality of coiled/[0210]helical links632 is placed theside636 of theexpandable structure602 to connect onering612 to anotherring612. The plurality of coiled/helical links634 is place on theside638 that is opposite theside636.
• When expanded (or stretched) the lengths on the[0211]side636 and theside638 are different due to the difference in the linear lengths. Theside638 is shorter than theside636 thus, theexpandable structure602 is curved toward theside638 as shown in FIGS.48-49. Theexpandable structure602 with this configuration can be deployed in theCS208 using method previously described (e.g., see FIG. 43).
• In one embodiment, the coiled/[0212]helical links632 and634 shown in FIGS.46-49 may have the same configurations (not shown). Both the coiled/helical links632 and634 may have the same number of coils, periods, or turns and essentially, the same linear length. Each of the coiled/helical links632 and634 is made of a different material or a material having a different tension property. Each of the coiled/helical links632 and634 thus has a different tension strength from each other. When the same force is used to expand theexpandable structure602, the sides of theexpandable structure602 expands differently. For example, theside638 may have the coiled/helical links632 that is made of a thicker material that has a higher tension strength while theside636 may have the coiled/helical links634 that is made of a thinner material that has a lower tension strength. When expanded, theexpandable structure602 curves toward theside638.
• In one embodiment, to provide the[0213]expandable structure602 with a curve shape, wave-like links of different linear lengths are used to hold the expandable rings612 together as shown in FIG. 50. The expandable rings612 are held together by a first plurality of wave-like links640 and a second plurality of wave-like links642. The first plurality of wave-like links640 is placed on theside646 of theexpandable structure602. The second plurality of wave-like links642 is placed on theside648 of theexpandable structure602.
• Each of the first plurality of wave-like links[0214]640 has a fully stretched length that is longer than each of the second plurality of wave-like links642. Each of the first plurality of wave-like links640 includes more sinusoidal waves than each of the second plurality of wave-like links642. Alternatively, each of the first plurality of wave-like links640 has greater linear length along the path between two links than each of the second plurality of wave-like links642. When therings612 are held together by these two different lengths of links,640 and642, theexpandable structure602 curves toward theside648 where thelinks642 are shorter. Theexpandable structure602 with this configuration can be deployed in theCS208 using a method previously described (e.g., see FIG. 43).
• In one embodiment, the[0215]links640 and642 shown in FIG. 50 may have the same configurations (not shown). Each of thelinks640 and642 is made of a different material or a material having a different tension property. Each of thelinks640 and642 thus has a different tension strength from each other. When the same force is used to expand theexpandable structure602, the sides of theexpandable structure602 expands differently. For example, theside648 may have thelinks642 that is made of a thicker material that has a higher tension strength while theside646 may have the links640 that is made of a thinner material that has a lower tension-strength. When expanded, theexpandable structure602 curves toward theside648.
• FIG. 51 illustrates an exemplary delivery device[0216]650 that can be used to deliver theannuloplasty device601 that includes theexpandable structure602 and theligature600 to theCS208 to reshape theannulus209 of themitral valve210. The delivery device650 is one type of a rapid exchange catheter well known in the art. It is to be understood that other methods can be used to deliver theannuloplasty device601 without departing from the scope of the present invention.
• The delivery device[0217]650 includes anexpandable balloon11 for deploying theannuloplasty device601 which resides in the CS208 (not shown here but see FIG. 29). The delivery device650 further includes aguidewire13 to guide portion (the distal portion) of the delivery device650 into theCS208. As shown in FIG. 51, theannuloplasty601 comprising theligature600 couples to anexpandable structure602, adistal anchoring member604, and aproximal anchoring member606 are disposed within the delivery device650. In one embodiment, theannuloplasty device601 as described above is disposed within aprotective sheath652 of the delivery device650. In one embodiment, thedistal anchoring member604 anchors into the left trigone and theproximal anchoring member606 anchors into the right trigone.
• In one embodiment, the delivery device[0218]650 further includeshandle section660 located proximally of the delivery device650. The delivery device650 includes aretracting mechanism662 for retracting theprotective sheath652. The delivery device650 includes aport664 for pressurizing a lumen of the delivery device650 that communicates with the lumen of theinflatable balloon12. Theport664 thus enables theballoon12 to be inflated, for example by pressure or fluid. The delivery device650 includes aport666 that allows access to the guidewire lumen of the delivery device650 for theguidewire13 to pass through. Theport666 also enables control of theguidewire13 as theguidewire13 is advanced into theCS208.
• In one embodiment, the[0219]guidewire13 is inserted into a vein the body of a patient through an introducer (not shown) as is well known in the art. Aguide catheter654 is placed over theguidewire13 through the introducer into the vessel lumen (the vein). Theguidewire13 and theguide catheter654 are advanced through the vessel to the right atrium and into the coronary sinus. Theannuloplasty device601 within theprotective sheath652 is then loaded on or over theguidewire13 and within the inner diameter of theguide catheter654 and delivered to a location in theCS208 adjacent to themitral valve210. Theprotective sheath652 is then retracted slightly and proximally relative to theannuloplasty device601 to expose thedistal anchoring member604. Thedistal anchoring member604 is then inserted or anchored into the left trigone. Theprotective sheath652 is further retracted proximally to expose theproximal anchoring component606. Theproximal anchoring component606 is inserted anchored into the right trigone. At this point, theligature600 is deployed within theCS208. Theexpandable balloon11 is then inflated to deploy theexpandable structure602 in the inner diameter of theCS208. In one embodiment, theexpandable structure602 is deployed against the inner diameter of theCS208. Theexpandable structure602 thus ensures thatCS208 stays open and unobstructed by theannuloplasty device601. Theexpandable structure602 does not necessarily function in opening up theCS208.
• In one embodiment, the distal end portion of the[0220]protective sheath652 may contain a slit or cutaway section (not shown) to allow theprotective sheath652 to expand an opening, which will slide over theannuloplasty device601 as theprotective sheath652 is retracted during deployment.
• In one embodiment, the[0221]protective sheath652 also acts as a straightening device (replacing the need for the straightening wire626) to temporarily straighten theexpandable structure602 during delivery and deployment. Theprotective sheath652 also acts as a straightening device to temporarily straighten theligature600. Once theligature600 and theexpandable structure602 is placed in theCS208, the withdrawal of theprotective sheath652 allows theexpandable structure602 that is curved to conform or return to a particular curve to return to its curved shape. In another embodiment, once fully deployed, theexpandable structure602 acts to maintain or support the curvature of theligature600.
• After the[0222]annuloplasty device601 is fully deployed, theligature600 and theexpandable structure602 is fully deployed within theCS208, thedistal anchoring member604 anchored into an area in the left trigone, and theproximal anchoring member606 anchored into an area in the right trigone. In one embodiment, theligature600 is pressed against the inner wall of theCS208 on the side that faces themitral valve annulus209. In one embodiment, the curvature of theligature600 reshapes the size of themitral annulus209. In one embodiment, the curvature of theligature600 together with the curvature of theexpandable structure602 reshape the size of themitral annulus209.
• It is to be understood that the delivery device[0223]650 can be made from materials and designs similar to current stent delivery systems. The delivery device650 could be of the over-the-wire or rapid-exchange styles of stent delivery systems as known in the art. The delivery device650 also could include materials or be made of materials that are compatible with X-ray, ultra sound of Magnetic Resonance Imaging (MRI) methods for the purpose of visualizing the delivery, placement and deployment of theannuloplasty device601.
• FIG. 52 illustrate an[0224]exemplary annuloplasty device701 which can be deployed in theCS208 to reshape themitral valve annulus209. Theannuloplasty device701 is similar to theannuloplasty device601 previously described. Theannuloplasty device701 however does not include theexpandable structure602.
• Similar to the[0225]annuloplasty device601, theannuloplasty device701 includes aligature600, adistal anchoring member604 and aproximal anchoring member606 which may be coils, helixes, anchors, hooks, barbs, screws, flanges, and other feature that allow the anchoring members to penetrate and attach to a myocardial tissue (or cardiac tissue). Again, it is to be appreciated that each of thedistal anchoring member604 and606 may include a plurality of anchors. For instance, thedistal anchoring member604 may include three anchors604a,604b, and604cand theproximal anchoring member606 may include three anchors606a,606b, and606c. In one embodiment, theligature600 extends into thedistal anchoring member604 and theproximal anchoring member606. In other words, theligature600, thedistal anchoring member604, and theproximal anchoring member606 are made of the same piece.
• The[0226]ligature600 is sufficient sized to have a surface area that will prevent theligature600 from cutting through the wall of the blood vessel (e.g., the CS208) once thedistal anchoring member604 and theproximal anchoring member606 are deployed. In one embodiment, theligature600 includes a flat and wide surface609 and/or a flat and wide surface611. One of these surfaces (609 and611) is the side that is in immediate contact with the inner wall of theCS208, for example, the surface611 is deployed to be in immediate contact with the inner wall of theCs208. Since the surface611 is sufficiently wide and flat, theligature600 is prevented from cutting through the wall of theCS208.
• In one embodiment, the[0227]ligature600 includes a plurality ofopenings613 created into theligature600. In one embodiment, theopenings613 facilitate the anchoring of theligature600 onto the inner wall of theCS208.
• All other aspects of the[0228]annuloplasty device701 are similar to theannuloplasty device601. Theannuloplasty device701 can be deployed using a delivery catheter651 illustrated in FIG. 53. The delivery catheter651 is similar to the delivery catheter650 previously described with the addition of aninner sheath653. The delivery device651 can be a type of a rapid exchange catheter well known in the art. It is to be understood that other methods can be used to deliver theannuloplasty device701 without departing from the scope of the present invention.
• To deploy the[0229]annuloplasty device701, theguidewire13 is inserted into a vein the body of a patient through an introducer (not shown) as is well known in the art. Aguide catheter654 is placed over theguidewire13 through the introducer into the vessel lumen (the vein). Theguidewire13 and theguide catheter654 are advanced through the vessel to the right atrium and into the coronary sinus. Theannuloplasty device701 is disposed within theprotective sheath652 of the delivery device651. Theprotective sheath652 is then loaded on or over theguidewire13, within the inner diameter of theguide catheter654, and delivered to a location in theCS208 adjacent to themitral valve210. Theprotective sheath652 is then retracted slightly and proximally relative to theannuloplasty device604 to expose thedistal anchoring member604 of theligature600 as shown in FIGS.54A-54B. Thedistal anchoring member604 is then inserted or anchored into the left trigone. Theprotective sheath652 is further retracted proximally to expose theproximal anchoring member606 of theligature600 as shown in FIG. 54C. Theproximal anchoring component606 is inserted anchored into the right trigone. Then, theannuloplasty device701 can be completely released from the delivery device651 as shown in FIG. 54D. A pushpin or a mechanism (not shown) can be included within the delivery device651 to release theannuloplasty device701.
• In one embodiment, the distal end portion of the[0230]protective sheath652 may contain a slit or cutaway section (not shown) to allow theprotective sheath652 to expand and open to allow theprotective sheath652 to slide over theannuloplasty device701 as theprotective sheath652 is retracted during deployment.
• In one embodiment, the[0231]protective sheath652 also acts as a straightening device to temporarily straighten theannuloplasty device701 during delivery and deployment. Once theannuloplasty device701 is placed in theCS208, the withdrawal of theprotective sheath652 allows the supporting structure that is curved to a particular curve to return to its curved shape as shown in FIG. 54D.
• After the[0232]annuloplasty device701 is fully deployed, thedistal anchoring member604 anchored into an area in the left trigone, theproximal anchoring member606 anchored into an area in the right trigone, and theligature600 is pressed against the wall of theCS208 on the side that faces themitral valve annulus209. In one embodiment, the curvature of theligature600 reshapes themitral annulus209. In one embodiment, the curvature of theligature600 together with the curvature of theexpandable structure602 reshape themitral annulus209.
• It is to be understood that the delivery device[0233]651 can be made from materials and designs similar to current stent delivery systems. The delivery device651 could be of the over-the-wire or rapid-exchange styles of stent delivery systems as known in the art. The delivery device651 also could include materials or be made of materials that are compatible with X-ray, ultra sound of Magnetic Resonance Imaging (MRI) methods for the purpose of visualizing the delivery, placement and deployment of theannuloplasty device701.
• FIGS.[0234]55A-55B illustrate cross-sectional views of anexemplary annuloplasty device900 that can be deployed in theCS208 to reshape themitral valve annulus209. In one embodiment, theannuloplasty device900 reduces the diameter of the arc that theCS208 circumscribes.
• The[0235]annuloplasty device900 comprises adistal anchoring member902, aproximal anchoring member904, and a spring-like spine906. The spring-like spine906 is constructed from a shape-memory alloy (e.g., Nitinol), which, generate a cinching force that is required to reduce the diameter of theCS208 and themitral valve annulus209. During deployment, the spring-like spine906 is stretched out for easy delivery as shown in FIG. 55A. After deployment, the spring-like spine906 returns to the original shape as shown in FIGS. 55B and 55C. The spring-like spine906 may be constructed to have the original shape as shown in FIG. 55C or a more expanded shape as shown in FIG. 55B. The spring-like spine906 may be constructed of a single unit by laser cutting using Nitinol or other shape-memory material. The spring-like spine906 can be welded together with thedistal anchoring member902 and theproximal anchoring member904 using conventional methods (e.g., laser welding). The spring-like spine906 can also be cut from a cylindrical tube or wound with wire using methods well known to those skilled in the art.
• The[0236]distal anchoring member902 and theproximal anchoring member904 are similar to previously described for theannuloplasty device601. Thedistal anchoring member902 and theproximal anchoring member904 function to grip and pull onto the venous tissue as the spring-like spine906 resumes its shape after deployment. In one embodiment, each of thedistal anchoring member902 and theproximal anchoring member904 is formed much like a conventional stent with modification so that each includes alink908 that allows it to be attached to the spring-like spine906. Additionally, each of thedistal anchoring member902 and theproximal anchoring member904 can be made slightly larger than the inner diameter of theCS208 such that when deployed, there is sufficient force for thedistal anchoring member902 and theproximal anchoring member904 to grip, anchor, or deploy against the inner diameter of theCS208.
• In one embodiment, each of the[0237]distal anchoring member902 and theproximal anchoring member904 includes thelink908 that is constructed to be thicker than other links typically present in a conventional stent as shown in FIG. 56. The thickness of thelink908 should be sufficient for the spring-like spine906 to be attached to each of thedistal anchoring member902 and theproximal anchoring member904.
• In one embodiment, each of the[0238]distal anchoring member902 and theproximal anchoring member904 is constructed to havecrowns910 with out-of-plane expansions or fish-scaling effects as shown in FIG. 57. This feature can be accomplished by adjusting the thickness of thestruts912 relative to the width ratio of thecrowns910. FIG. 57 represents, in one embodiment, an enhancement to traditionally cut stents which will allow the distal and proximal anchors to grip the tissue in the presence of the cinching force generated by the constriction of the spine. This figure illustrates the use of barbs or hooks that may be welded to the links and/or struts of the distal and proximal anchoring devices. These would function in a fashion similar those described for other embodiments of the anchoring members.
• FIG. 58 illustrates that in one embodiment, the[0239]crowns910 on thedistal anchoring member902 are pointed toward the proximal end of theannuloplasty device900. Thecrowns910 on theproximal anchoring member904 are pointed toward the distal end of theannuloplasty device900. The orientation of thecrowns910 in the manner mentioned ensured that thedistal anchoring member902 and theproximal anchoring member904 are embedded deeper into the tissue of the wall of theCS208 as the spring-like spine906 resumes its original shape. One advantage for orienting thecrowns910 as depicted in FIG. 58 is to take advantage of the fish-scaling effect mentioned above. When an anchoring member (e.g., thedistal anchoring member902 or the proximal anchoring member904) is expanded, thecrowns910 will expand out of the cylindrical plane defined by the main body of the anchoring member as seen in the side views of FIG. 58. Adjusting the crown width to thickness ratio controls the degree of out-of-plane deformation. The crown width and thickness have been labeled1 and2, respectively, in FIG. 58. When theannuloplasty device900 is fully deployed, the cinching force generated by the contraction of the spring-like spine906 will cause the anchoring members to further embed themselves into the tissue much like barbs or hooks.
• In one embodiment, each of the[0240]distal anchoring member902 and theproximal anchoring member904 includes at least oneanchor914 as shown in FIG. 57. Theanchor914 further aid thedistal anchoring member902 and theproximal anchoring member904 in anchoring into the tissue of the wall of theCS208.
• FIG. 59A represents the spring-[0241]like spine906 as if it were flattened onto the plane of the page. This embodiment of the spring-like spine906 has a pure sinusoidal shape (which resembles a sine wave shape). The spring-like spine906 is not restricted to a sinusoidal shape, but may also take on the repeating keyhole-like shape of a typical stent ring in order to exploit flexibility, strength, expansion and contraction characteristics. In an alternative embodiment, the spring-like spine906 is aspine936 that has the repeating keyhole-like shape of a typical stent ring as illustrated in FIG. 59D.
• FIG. 59B illustrates the spring-[0242]like spine906 wrapped around the x-axis as if thespine906 has been cut from a cylindrical tube. FIG. 59C depicts the final structure of thespine906 in a top view and a front view. The spring-like spine906 is transformed from the configuration shown in FIG. 59B by wrapping itself around the y-axis. FIG. 59C represents the final shape of the spring-like spine906, which has a predetermined curvature. The spring-like spine906 may be characterized as a tubular spring that has been wrapped around the y-axis such that it circumscribes a particular arc (e.g., the arc of the CS208).
• The spring-like spines described may have features are adjusted to achieve specific functionality. For example, the spring-like spines could be modified by adjusting the period or frequency of the repeating pattern, the amplitude of the repeating pattern, or the number of repeating patterns along the length of the spines.[0243]
• The[0244]annuloplasty device900 can be delivered into theCS208 using a conventional method and a conventional delivery device or the delivery devices previously described.
• FIG. 60 illustrates an[0245]exemplary annuloplasty device1000 that can be deployed in theCS208 to reshape themitral valve annulus209. In one embodiment, theannuloplasty device1000 reduces the diameter of the arc that theCS208 circumscribes thereby reshaping themitral valve annulus209.
• The[0246]annuloplasty device1000 comprises adistal anchoring member1002, aproximal anchoring member1004, and aligature1010. In one embodiment, theligature1010 is constructed from a shape-memory alloy (e.g., Nitinol), which, generate a cinching force that is required to reduce the diameter of theCS208 and themitral valve annulus209. During deployment, theligature1010 may be stretched out for easy delivery. After deployment, theligature1010 returns to the original shape which may have a predetermine curvature for which theCS208 and themitral valve annulus209 are to conform to as shown in FIG. 60.
• The[0247]annuloplasty device1000 may be constructed of a single unit by laser cutting using Nitinol or other shape-memory material. Theannuloplasty device1000 can also be cut from a cylindrical tube or wound with wire using methods well known to those skilled in the art. Alternatively, theligature1010 may be welded together with thedistal anchoring member1002 and theproximal anchoring member1004 using conventional methods (e.g., laser welding).
• The[0248]distal anchoring member1002 and theproximal anchoring member1004 are similar to previously described for theannuloplasty device601. Thedistal anchoring member1002 and theproximal anchoring member1004 function to grip and pull onto the venous tissue as theligature1010 resumes its shape after deployment. In one embodiment, each of thedistal anchoring member1002 and theproximal anchoring member1004 is configured to have a coiled or helical shapes as shown in FIGS.61A-61E. The coiled/helical shaped anchoring members (1002 and1004) can be delivered at a small profile and expand into theCS208. The ends of the coiled/helical shaped anchoring members can protrude through theCS208 and into the left or the right trigone, the annulus tissue, or other myocardial tissue proximate theCS208 for better anchoring. Alternatively, at least one anchor can be attached or included to the ends of the coiled/helical shaped anchoring members as shown in FIG. 60. In FIG. 60, thedistal anchoring member1002 includes ananchor1006 and theproximal anchoring member1004 includes ananchor1008. The anchor can be a barb, hook, helix, coil, flange, screw, staple, and rivet, to name a few.
• FIG. 61A illustrate an embodiment of the annuloplasty device with the[0249]proximal anchoring member1004 and thedistal anchoring member1002 having coils that turn in opposite direction. Theproximal anchoring member1004 and thedistal anchoring member1002 are essentially mirror image of each other. In one embodiment, thedistal anchoring member1002 has a clockwise rotation while theproximal anchoring member1004 has a counter-clockwise rotation. As can be seen, thedistal anchoring member1002, theligature1010, and theproximal anchoring member1004 are parts of one continuous structure made of the same material.
• Pulling on the[0250]ligature1010 induces the coil stacking of thedistal anchoring member1002 and theproximal anchoring member1004 which provide more anchoring force and support for theannuloplasty device1000. In one embodiment, theligature1010 begins at the most distal end portion of thedistal anchoring member1002 and at the most proximal end portion of theproximal anchoring member1004 as illustrated in FIG. 61B.
• In an alternative embodiment, the[0251]annuloplasty device1000 includes multiple structures as shown in FIG. 61C. In this embodiment, thedistal anchoring member1002 includes at least two coils wound in the same direction and theproximal anchoring member1004 also includes at least two coils wound in the same direction. Theligature1010 can be a single-stranded structure as shown in FIG. 61C. Alternatively, theligature1010 can be a double-stranded structure as shown in FIG. 61D. Theannuloplasty device1000 with at least two coils provides additional support to thedistal anchoring member1002 and theproximal anchoring member1004.
• In another alternative embodiment, the[0252]annuloplasty device1000 includes multiple coils each turning an opposite direction and interlocking one another as illustrated in FIG. 61E. In this embodiment, theligature1010 can be a single-stranded structure as shown in this figure or a double-stranded structure similar to the one shown in FIG. 61D.
• In one embodiment, the[0253]ligature1010 itself could include coiled or helical turn to form aligature1014 as shown in FIG. 61F. Pulling on theligature1014 exerts more torques onto thedistal anchoring member1002 and theproximal anchoring member1004 thus, providing more radial anchoring force to these anchoring members.
• The[0254]annuloplasty device1000 can be delivered into theCS208 using a conventional method and a conventional delivery device or the delivery devices previously described.
• FIGS.[0255]62A-62D illustrate an exemplary embodiment of the present invention that can be used to treat a defective heart valve such as that seen in a mitral valve regurgitation condition. As previously discussed, anchoring members may be placed or anchored in the coronary sinus at two opposite ends with a connecting member that can pull the anchoring members toward each other in order to change the shape of the mitral valve annulus. In many instances, adjustability and removability of the anchoring members without complication (e.g., surgery) are desirable. The embodiments shown in the FIGS.62A-62D describe-the use of expandable baskets as anchoring members to deploy in the coronary sinus (or other blood vessel).
• In FIGS.[0256]62A-62D, animplantable device2202, which can be an annuloplasty device, is moveably disposed within adelivery sheath2204. Theimplantable device2202 includes a distalexpandable basket2230 and a proximalexpandable basket2236 connected by a connectingmember2242. The distalexpandable basket2230 and the proximalexpandable basket2236 are delivered in their collapsed or compressed state. Thedelivery sheath2204 functions to constrain the distalexpandable basket2230 and the proximalexpandable basket2236 in their collapsed state. Once delivered to their respective and desired location, the distalexpandable basket2230 and the proximalexpandable basket2236 are allowed to expand and deploy against the inner wall of the coronary sinus (or blood vessel), in one embodiment. To deploy the distalexpandable basket2230 and the proximalexpandable basket2236, thedelivery sheath2204 is withdrawn to allow the distalexpandable basket2230 and the proximalexpandable basket2236 to expand.
• The[0257]implantable device2202 is releasably coupled to anactuator2206 at ajunction2208. Theactuator2206 is coupled to the implantable device by coupling to the proximal end of the connectingmember2242. Theactuator2206 is used to facilitate the deployment of theimplantable device2202. Theactuator2206 is also used to apply tension on the distalexpandable basket2230, theproximal basket2236, and the connectingmember2242 in order to reshape the blood vessel or the coronary sinus, in one embodiment.
• FIG. 62A shows the[0258]implantable device2202 contained in thedelivery sheath2204. As shown in this figure, the distalexpandable basket2230 and the proximalexpandable basket2236 are in their collapsed state.
• FIG. 62B shows the distal[0259]expandable basket2230 being deployed. Once thedevice2202 is in position and the distalexpandable basket2230 is in the desired location within the blood vessel or the coronary sinus, thedelivery sheath2204 is retracted to allow the distalexpandable basket2230 to expand and anchor or deploy against the inner wall of the blood vessel (or other vessel) at the desired location.
• FIG. 62C shows the[0260]proximal basket2236 being deployed. The proximalexpandable basket2236 is deployed while tension is applied to the actuator2206 (e.g., as is needed to change the shape of the blood vessel, the coronary sinus, and/or the mitral valve annulus). After the proximalexpandable basket2236 is placed in the desired location, with tension being applied, thedelivery sheath2204 is retracted further proximally to allow the proximalexpandable basket2236 to expand and anchor or deploy. In one embodiment, the proximalexpandable basket2236 is deployed within the blood vessel similarly to the distalexpandable basket2230. In another embodiment, the proximalexpandable basket2236 is deployed outside of the ostium of the coronary sinus in the right atrium and held against the ostrium as shown in FIG. 62E.
• When there is need for adjustment or repositioning of the proximal[0261]expandable basket2236 or the distalexpandable basket2230, the delivery sheath is advanced over the proximalexpandable basket2236 or the distalexpandable basket2230 to collapse the proximalexpandable basket2236 or the distalexpandable basket2230 to allow for repositioning or adjustment.
• FIG. 62D shows the removal of the[0262]actuator2204 and thedelivery sheath204 after proper positioning of the distalexpandable basket2230 and the proximalexpandable basket2236 is achieved. After the distalexpandable basket2230 and the proximalexpandable basket2236 are deployed or anchored in place, the connectingmember2242 applies tension to pull on thebaskets2230 and2236. The tension is sufficient to reshape the coronary sinus or the blood vessel. The connectingmember2242 may be positioned on or proximate a side of the inner wall of the blood vessel or the coronary sinus.
• FIGS.[0263]63-64 illustrate enlarged views of thejunction2208, which is the connecting point for theactuator2206 and theimplantable device2202. In one embodiment, theactuator2206 is coupled to theimplantable device2202 through aconnection mechanism2218 as shown in FIG. 63. Theconnection mechanism2218 includes ascrew thread structure2220 and a complimentaryscrew thread structure2222. Thescrew thread structure2220 couples to or extends from theactuator2206 at thedistal end section2252 of theactuator2206. Thescrew thread structure2222 couples to or extends from theimplantable device2202 at theproximal end section2250 of theimplantable device2202. One of thescrew thread structure2220 and thescrew thread structure2222 can be a female thread structure while the other can be a complimentary male thread structure. In FIG. 63, thescrew thread structure2222 is a female thread structure and thescrew thread structure2220 is a male thread structure. Thescrew thread structure2220 andscrew thread structure2222 engage one another to couple theimplantable device2202 to theactuator2206. Thescrew thread structure2220 and thescrew thread structure2222 disengage one another to release or detach the actuator2206 from theimplantable device2202. Thus, during deployment, thescrew thread structure2220 and thescrew thread structure2222 engage one another to allow theactuator2206 to move theimplantable device2202 and after the deployment, thescrew thread structure2220 and thescrew thread structure2222 disengage one another to allow theactuator2206 to be detached from theimplantable device2202.
• It is to be appreciated that there are many connection mechanisms that rely on a rotary and/or longitudinal motion and/or release of the[0264]implantable device2202. Alternatively, theactuator2206 can be coupled to theimplantable device202 using aloop connection system2224 as illustrated in FIG. 64. Theproximal section2250 of theimplantable device2202 may include a loop, opening, or aslot2228. Thedistal section2252 of theactuator2206 may include awire loop2226 that can be inserted through theslot2228. Thewire loop2226 keeps theactuator2206 coupled to theimplantable device2202 until the removal of thewire loop2226 from theslot2228. Thewire loop2226 may be removed by releasing one end of thewire loop2226 while pulling on the other end of thewire loop2226. Thewire loop2226 holds theimplantable device2202 against theactuator2206 such that theimplantable device2202 can be pushed or pulled by theactuator2206. Thewire loop2226 may simply act to couple theimplantable device2202 to theactuator2206 while theactuator2206 is the member that performs the controlling or moving of theimplantable device2202.
• The[0265]delivery sheath2204 is made out of a biocompatible material such as those typically used for a catheter. Thedelivery sheath2204 can be made out of a polymer commonly used in catheter construction such as Nylon, Pebax, Polyurethane, PEEK, Polyolefin, etc... Thedelivery sheath2204 is flexible but need not be and can be made to have preformed curvature to facilitate the maneuvering of thedelivery sheath2204 into the target blood vessel (e.g., a coronary sinus). In one embodiment, thedelivery sheath2204 is substantially smaller compared to the blood vessel that thedelivery sheath2204 is to be inserted into. Thedelivery sheath2204 introduces theimplantable device2202 to a treatment site (e.g., a site within the blood vessel). The treatment site can be a coronary sinus that substantially encircles a mitral valve and mitral valve annulus (previously shown).
• The[0266]delivery sheath2204 constrains theimplantable device2202 in the pre-delivery or pre-deployment state. In one embodiment, in the pre-deployment state, the distalexpandable basket2230 and the proximalexpandable basket2236 are in collapsed state as shown in FIG. 62A that allow them to be conveniently disposed within thedelivery sheath2204. As discussed, retraction of thedelivery sheath2204 allows the distalexpandable basket2230 and the proximalexpandable basket2236 to be deployed to their non-compressed state.
• In one embodiment, to deliver the[0267]implantable device2202 to the blood vessel, a sub-selective sheath (not shown) is used. Sub-selective delivery is known in the art. In this embodiment, the sub-selective sheath is advanced over a guidewire into the blood vessel (or the coronary sinus) using conventional technique. The sub-selective sheath is advanced over the guidewire to the anchor site for the distalexpandable basket2230. The guidewire is then withdrawn. Theimplantable device2202 constrained in thedelivery sheath2204 is advanced to the anchor site through the sub-selective sheath. To deploy theimplantable device2202, the sub-selective sheath is retracted proximally to allow sufficient room for the deployment. After the distalexpandable basket2230 is in position, thedelivery sheath2204 is retracted as previously discussed. Then, with tension applied, after the proximalexpandable basket2236 is in position, thedelivery sheath2204 is also retracted as previously discussed. The sub-selective sheath can be withdrawn completely when deployment is achieved.
• In other embodiments, the[0268]delivery sheath2204 can be configured to include a lumen that can accommodate a guidewire. With this configuration, thedelivery sheath2204 can be advanced into the blood vessel and to the anchor site without the sub-selective sheath. In such embodiments, thedelivery sheath2204 can be advanced over the guidewire into the blood vessel. The deployment can then be carried out as previously discussed. In other embodiments, the connectingmember2242 is configured with anatraumatic tip2241 to prevent injury during advancement especially when thedelivery sheath2204 is used to deliver theimplantable device2202.
• During deployment, the[0269]implantable device2202 can be flushed with a fluid to lubricate theimplantable device2202 and the inner space of thedelivery sheath2204 to minimize friction between theimplantable device2202 and thedelivery sheath2204 so as to allow the distal and proximalexpandable baskets2230 and2236 to move out of thedelivery sheath2204 for deployment. Theimplantable device2202 may be also coated with a lubricious material that facilitates the movement of the distal and proximalexpandable baskets2230 and2236 in and out of thedelivery sheath2204.
• The delivery sheath[0270]2214 may also include radiopaque markers (not shown) to provide positioning information. The delivery sheath2214 may also include other type of markers compatible with various types of imaging techniques known in the art such as echo imaging, infrared illuminations x-ray, and magnetic resonance imaging.
• The[0271]actuator2206 may be a hollow or a solid member, rod, or wire and may be coated with a lubricious material that facilitates the movement of theactuator2206 in and out of thedelivery sheath2204. Theactuator2206 is releasably coupled to theimplantable device2202 in a way that allows theactuator2206 to engage or disengage, attach to or detach from theimplantable device2202 when desired. For deployment of theimplantable device2202, theactuator2206 engages theimplantable device2202 to move and/or facilitate in deploying the implantable device. After the deployment of theimplantable device2202, theactuator2206 disengages theimplantable device2202 and can be withdrawn from the blood vessel or the coronary sinus.
• FIGS.[0272]65A-65C illustrate exemplary embodiments of the distalexpandable basket2230 and the proximalexpandable basket2236. The distalexpandable basket2230 and the proximalexpandable basket2236 are similar. Each of the distalexpandable basket2230 and the proximalexpandable basket2236 comprises anexpandable strut assembly3024 which possesses spring-like or self-expanding properties and can move from a compressed or collapsed position as shown in FIG. 62A to an expanded or deployed position shown in FIGS.62B-62D.
• In FIG. 65A,[0273]expandable strut assembly3024 includes an elongatedcylindrical center portion3034 and proximal anddistal end portions3036 and3038 which are shaped as truncated cones, terminating at proximal and distal, hollow, cylindrical,collars3040 and3042. Starting from theproximal collar3040, thestrut assembly3024 comprises a plurality ofindividual struts3044 which taper upward to form the proximaltruncated cone portion3036 of the of thestrut assembly3024. Thestruts3044 continue, extending longitudinally, to form the elongated, straight,center portion3034 of the strut assembly. Thestruts3044 then taper downward forming the distaltruncated cone portion3038 of the strut assembly and terminate at thedistal collar3042.Arrow3046 shows the angle that the distaltruncated cone portion3038 makes with thecenter portion3034. While the figures show only four individual struts, the expandable basket is not limited to this configuration as strut assemblies containing more or less struts are practical.
• FIG. 65B illustrates an alternative configuration of the individual struts[0274]3044. Thestruts3044 in FIG. 65A have straight shapes. Thestruts3044 in FIG. 65B have spiral shapes, which can make the collapsing or compressing of the expandable baskets easier. Thestruts3044 can have other suitable shapes not shown here.
• FIG. 65C illustrates yet another alternative configuration of each of the distal[0275]expandable basket2230 and the proximalexpandable basket2236. Each of the distalexpandable basket2230 and the proximalexpandable basket2236 includes aproximal strut assembly3042 which includes a number of self-expandingstruts3044 that extend radially outward from the unexpanded position, to an expanded, implanted position as previous discussed. Theproximal strut assembly3042 is coupled to adistal strut assembly3046, which also includes a number of self-expandingstruts3044 that extend radially out once placed in the expanded position. Theproximal strut assembly3042 anddistal strut assembly3046 are coupled together byintermediate links3050 which provide a region of increased bendability and flexibility to the basket. In this regard, theintermediate links3050 act similarly to a mechanical hinge to allow theproximal strut assembly3042 anddistal strut assembly3046 to move freely relative to each other when negotiating tortuous curves in the patient's anatomy. Enhanced flexibility of theintermediate links3050 can be achieved by decreasing the strut width or the strut thickness from that used for the proximal or distal strut assembly.
• The[0276]struts3044 of theproximal strut assembly3042 are attached to acollar3052 which can be rotatably attached to the connectingmember2242. The opposite ends of eachstrut3044 are in turn attached to adeployment ring3054, also made from a self-expanding material, which aids in the expansion of theproximal assembly3042. Thedeployment ring3054 is shown having a number ofpleats3056 which helps when collapsing thering3054 to its delivery position. Thedistal strut assembly3046 may likewise include adeployment ring3054 attached to the ends of thestruts3044. In a like manner, thisdeployment ring3054 serves to expand the distal assembly as well. The deployment rings3054 are shown having a zigzag pattern which formspeaks3043 andvalleys3045 and other patterns such an undulations. Generally, theintermediate links3050 are connected to thepeaks3043 of the deployment rings3054 with the ends of thestruts3044 being connected to thevalleys3045 of thering3054. As a result, each of thebaskets2230 and2236 will enter thedelivery sheath2242 in a smoother fashion.
• Each of the strut assemblies described may be produced by several methods including electro-discharge machining and chemical etching. One method is to laser machine a thin-walled tubular member, such as a hypotube. In this procedure, a computer controlled laser cuts away portions of the hypotube following a pre-programmed template to form the desired strut pattern. Methods and equipment for laser machining small diameter tubing may be found in U.S. Pat. No. 5,759,192 (Saunders) and U.S. Pat. No. 5,780,807 (Saunders), which have been assigned to Advanced Cardiovascular Systems, Inc.[0277]
• The tubing used to make the strut assembly may be made of any biocompatible spring steel or shape memory alloy. The 300 series stainless steel alloys are well suited to this application as is type 316L stainless steel per ASTM F138-92 or ASTM F139-92 grade 2. Other suitable materials include nickel-titanium alloys, such as Nitinol, including nickel-titanium alloys with optional ternary element added, and wherein the alloy may be processed to varying degrees to achieve different stress-strain behavior such as superelasticity or linear pseudoelasticity. The ternary elements include, for example, platinum, palladium, chromium, iron, cobalt, vanadium, manganese, boron, aluminum, tungsten, or zirconium.[0278]
• Each of the distal[0279]expandable basket2230 and the proximalexpandable basket2236 is coupled to the connectingmember2242 at the center of each basket. The connectingmember2206 thus runs through the center of each of thebaskets2030 and2036. In one embodiment, distalexpandable basket2230 is fixed at one end (e.g., the distal end of the distal expandable basket2230) on the connectingmember2242 and not at the other end (e.g., the proximal end of the distal expandable basket2230). As shown in FIG. 66, the distalexpandable basket2230 is coupled to the connectingmember2242 at the distal end2030-D. The proximal end2030-P of the distalexpandable basket2230 is disposed over the connectingmember2242 but is not fixed to the connectingmember2242. The proximal end2030-P thus can slide along the connectingmember2242. This allows the distalexpandable basket2230 to easily expand and compress over the connectingmember2242. Similarly, the proximalexpandable basket2236 is coupled to the connectingmember2242 at the distal end2236-D. The proximal end2236-P of the proximalexpandable basket2236 is disposed over the connectingmember2242 but is not fixed to the connectingmember2242. The proximal end2236-P thus can slide along the connectingmember2242. This also allows the proximalexpandable basket2236 to easily expand and compress over the connectingmember2242.
• In one embodiment, the proximal[0280]expandable basket2236 is somewhat slideable over the connectingmember2242. Both the distal end2236-D and the proximal end2236-P of the proximal expandable basket are not fixed on the connectingmember2242. This embodiment provides animplantable device2202 with a wider range of adjustability. For example, oneimplantable device2202 can be used for various length and/or size of the blood vessel or the coronary sinus. In this embodiment, adistal stop2235 can be placed on the connectingmember2242. Thedistal stop2235 defines the distal travel distance for the proximal expandable basket2236 (e.g., the proximalexpandable basket2236 will not be able to travel pass the distal stop2235). The distal stop225 can be a ring, a band, or other suitable feature created on the connectingmember2242 as is known in the art.
• In one embodiment, a[0281]proximal end lock2237 is included in theimplantable device2202. Theproximal end lock2237 functions to allow for additional tension to be applied on theimplantable device2202 after the distalexpandable basket2230 and the proximalexpandable basket2236 are deployed. Theproximal end lock2237 also functions to lock or fix the position of the proximalexpandable basket2236 on the connectingmember2242, especially when the proximalexpandable basket2236 is not fixed on the connectingmember2242.
• Examples of a[0282]proximal end lock2237 can be found in U.S. Pat. No. 6,402,781 or publication WO 01/54,618. Configuration of a locking device that can be incorporated into theimplantable device2202 is known in the art.
• In one embodiment, the[0283]implantable device2202 is an annuloplasty device that can reshape a mitral valve and/or a mitral valve annulus. In one embodiment, theimplantable device2202 reduces the radius of the arc that a defective coronary sinus has thereby reshaping a mitral valve annulus that is adjacent the coronary sinus. In another embodiment, the implantable device reduces the curvature of the coronary sinus thus allowing the coronary sinus to exert pressure or force onto the mitral valve annulus, thus, bringing the leaflets of the mitral valve closer to each other.
• In one embodiment, a method for deploying a device percutaneously into the coronary sinus (e.g., such as any one the methods described herein) may be combined with a percutaneous method of deploying a device on the mitral valve (e.g., such as a support annulus around the mitral valve annulus or a set of joined clips which attach to the mitral valve's leaflets). In this embodiment, a general technique would include percutaneously deploying (e.g., with a first catheter) a device into the coronary sinus (e.g., near the mitral valve) and percutaneously deploying (e.g., with a second catheter) a device onto the mitral valve (e.g., a support annulus). Device which may be deployed onto the mitral valve or into the coronary sinus are described in several co-pending U.S. patent applications which are hereby incorporated herein by reference, these applications beings: (1) Apparatus and Methods for Heart Valve Repair, by inventors Gregory M. Hyde, Mark Juravic, Stephanie A. Szobota, and Brad D. Bisson, filed Nov. 15, 2002, Attorney Docket No. 05618.P3591; (2) Heart Valve Catheter, by inventor Gregory M. Hyde, filed Nov. 15, 2002, Attorney Docket No. 05618.P3456; (3) Valve Adaptation Assist Device, by inventors William E. Webler, James D. Breeding, Brad D. Bisson, Fira Mourtada, Gregory M. Hyde, Stephanie A. Szobota, Grabiel Asongwe, and Jefferey T. Ellis, filed Nov. 15, 2002, Attorney Docket No. 05618.P3665; (4) Valve Annulus Constriction Apparatus and Method, by inventors Peter L Callas and Richard Saunders, filed Nov. 15, 2002, Attorney Docket No. 05618.P3560; and (5) Apparatuses and Methods for Heart Valve Repair, by inventor Gregory M. Hyde, filed Oct. 15, 2002, Attorney Docket No. 05618.P3575.[0284]
• A kit (e.g., a kit of multiple catheters with instructions for use thereof) may be used to perform the combination of (a) percutaneously deploying (e.g., with a first catheter) a device into the coronary sinus (e.g., near the mitral valve) and (b) percutaneously deploying (e.g., with a second catheter) a device onto the mitral valve. For example, a first catheter, such as the medical device[0285]200A (FIG. 23), may be combined in a kit with a second catheter designed to percutaneously apply a member near the mitral valve, such as a support annulus to be attached on the mitral valve to reshape the mitral valve or a set of joined clips which grasp (e.g., attach to) the mitral valve leaflets.
• In one embodiment, a support annulus (or clips, ligature) percutaneously placed near a mitral valve region, or a device placed in the coronary sinus to treat the mitral valve, may be used to deliver or release a drug or therapeutic agent to treat mitral valve regurgitation. Various drugs are known in the art for treating mitral valve regurgitation. For example, administering nitroprusside (a vascular smooth muscle relaxant) may effectively diminish the amount of mitral regurgitation, thereby increasing forward output by the left ventricle and reducing pulmonary congestion. Inotropic agents such as dobutamine may also be administered to increase the force of contraction of the myocardium. In one embodiment, a percutaneous medical device to treat mitral valve regurgitation, such as a support annulus for resizing a mitral valve annulus, clips to ligate the mitral valve leaflets, or a device placed in the coronary sinus near the mitral valve region, may be coated with these exemplary drugs for delivery near the mitral valve region. The drugs may have timed-release features to be released slowly over a certain period of time. The drug eluting support annulus or other devices may also have the drug or agent dispersed on the surface of the support annulus or other devices, or co-dissolved in a matrix solution to be dispersed on the support annulus. Methods to coat the support annulus with a therapeutic drug include dip coating, spin coating, spray coating, or other coating methods commonly practiced in the art.[0286]
• In some cases, patients with defective heart valves may have concomitant coronary artery disease (CAD). As such, it may be advantageous for a support annulus to deliver a drug to treat occlusions in the artery or other related CAD such as vulnerable plaque. The drug to treat CAD may be delivered alone or in combination with drugs to treat mitral valve regurgitation. Drugs to treat CAD include, but are not limited to, statins, lipid lowering agents, antioxidants, extracellular matrix synthesis promoters, inhibitors of plaque inflammation and extracellular degradation, estradiol drug classes and its derivatives.[0287]
• In one embodiment, the drugs to treat CAD may be coated on a support annulus or other device using methods such as dip coating, spin coating, spray coating or other coating methods known in the art. The drug may alternatively be encapsulated in microparticles or nanoparticles and dispersed in a coating on the support annulus or other device. A diffusion limiting top-coat may optionally be applied to the above coatings. The active agents may optionally be loaded on a support annulus or other device together either by adding them together to the solution of the matrix polymer before coating, or by coating different layers, each containing a different agent or combination of agents. The drug eluting support annulus or other device may alternatively have an active agent or a combination of agents dispersed in a bioerodable annulus-forming polymer.[0288]
• The foregoing description describes percutaneous methods (e.g., catheter based techniques) for delivering the annuloplasty devices described herein. It will be appreciated that surgical (non-percutaneous) techniques may alternatively be used to deploy/deliver these annuloplasty devices.[0289]

Claims (18)

We claim:

1. A medical device comprising:

a delivery sheath;

an implantable device moveably disposed within the delivery sheath, the implantable device further comprises a distal expandable basket, a proximal expandable basket, and a connecting member coupling at a first end to the distal expandable basket and at a second end to the proximal expandable basket, each of the distal expandable basket and proximal expandable basket being collapsed during delivery and expanded after deployment; and

an actuator releasably coupling to the implantable device, the actuator to move the implantable device when coupled to the implantable device.

2. The medical device as inclaim 1 wherein the distal expandable basket is deployable against an inner wall of a coronary sinus adjacent a mitral valve annulus, the proximal expandable basket is deployable against the inner wall or at an entrance of the coronary sinus, and the implantable device to reshape the coronary sinus.

3. The medical device as inclaim 1 wherein the distal expandable basket is deployable against an inner wall of a coronary vein adjacent a mitral valve annulus, the proximal expandable basket is deployable against the inner wall or at an entrance of a coronary sinus, wherein the coronary vein and the coronary sinus are part of a vessel and the implantable device to reshape the vessel.

4. The medical device as inclaim 2 wherein each of the distal expandable basket and the proximal expandable basket includes a strut assembly that is collapsible and expandable, the delivery sheath to constrain each of the distal expandable basket and the proximal expandable basket, and retraction of the delivery sheath allows deployment of the distal expandable basket and the proximal expandable basket.

5. The medical device as inclaim 1 wherein the distal expandable basket is engageable to an inner wall of a blood vessel, the proximal expandable basket is engageable to the inner wall of the blood vessel, the connecting member is deployable on a side of the inner wall of the blood vessel, and the medical device reshapes the blood vessel.

6. The medical device as inclaim 1 wherein each of the distal expandable basket, and the proximal expandable basket is comprised of a shaped-memory material.

7. The medical device as inclaim 1 wherein the distal expandable basket includes a distal end that is fixed on the connecting member and a proximal end that is slideable along the connecting member.

8. The medical device as inclaim 1 wherein the distal expandable basket includes a proximal end that is fixed on the connecting member and a distal end that is slideable along the connecting member.

9. The medical device as inclaim 1 wherein the proximal expandable basket includes a proximal end that is fixed on the connecting member and a distal end that is slideable along the connecting member.

10. The medical device as inclaim 1 wherein the proximal expandable basket includes a distal end that is fixed on the connecting member and a proximal end that is slideable along the connecting member.

11. The medical device as inclaim 1 wherein the proximal expandable basket includes a proximal end and a distal end that are slideable over the connecting member and are not fixed on the connecting member and where the connecting member further includes a proximal lock and a distal stop to fix the proximal expandable basket at a location along the connecting member.

12. A method of implanting an implantable device in a blood vessel comprising:

advancing into a blood vessel a medical device that comprises a delivery sheath, an implantable device moveably disposed within the delivery sheath, and an actuator releasably coupling to the implantable device, the implantable device further comprises a distal expandable basket, a proximal expandable basket, and a connecting member coupling at a first end to the distal expandable basket and at a second end to the proximal expandable basket; and

deploying the distal expandable basket and the proximal expandable basket, each of which is delivered in a collapsed state and expanded after deployment, the distal expandable basket is deployed against the inner wall of the blood vessel at a first site, the proximal expandable basket is deployed against the inner wall of the blood vessel at a second site or outside the blood vessel and butting up against the blood vessel, the deploying reshapes the blood vessel.

13. The method as inclaim 12 wherein the blood vessel is a coronary sinus and wherein after the deploying, the connecting member is deployed on a side of the inner wall of the coronary sinus that is adjacent a mitral valve annulus.

14. The method ofclaim 12 wherein the deploying further comprising:

advancing the delivery sheath distally into the blood vessel;

positioning the delivery sheath to have that the distal expandable basket at a desired deployed location within the blood vessel;

retracting the delivery sheath proximally to the distal expandable basket to deploy the distal expandable basket;

applying tension on the actuator while positioning the proximal expandable basket into another desired deployed location;

retracting the delivery sheath proximally to the proximal expandable basket to deploy the proximal expandable basket; and

detaching the actuator from the implantable device after the distal expandable basket and the proximal expandable basket are deployed.

15. The method ofclaim 14 wherein the blood vessel is a coronary sinus.

16. The method ofclaim 12 further comprises advancing the delivery sheath back over the proximal expandable basket or the distal expandable to collapse the proximal expandable basket or the distal expandable in order to adjust, reposition, or remove the implantable device.

17. A method for treating a defective heart valve comprising:

advancing into a blood vessel that is adjacent the defect heart valve a medical device that comprises

a delivery sheath;

an implantable device moveably disposed within the delivery sheath, the implantable device further comprises a distal expandable basket, a proximal expandable basket, and a connecting member coupling at a first end to the distal expandable basket and at a second end to the proximal expandable basket; and

an actuator releasably coupling to the implantable device;

retracting the delivery sheath sufficiently to deploy the distal expandable basket;

retracting the delivery sheath sufficiently to deploy the proximal expandable basket;

optionally, advancing the delivery sheath over one or both of the proximal expandable basket and the distal expandable basket to adjust or reposition one or both of the proximal expandable basket and the distal expandable basket; and

removing the actuator when deployment is complete.

18. The method ofclaim 17 wherein the blood vessel is a coronary sinus.

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